Intensive Care (ICU)ECMO-SEDNCT07580781
Feasibility of Protocolised Analgosedation in ECMO
A study testing Sedation protocol in people with Intensive Care (ICU) and Respiratory Distress Syndrome (RDS), run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU), Respiratory Distress Syndrome (RDS), Sedation and Analgesia
- What is being tested?
- Sedation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and older
- Receiving IV continuous infusions of analgosedation medication
- Receiving ECMO treatment
Who cannot join
- There will be no exclusion criteria as analgosedation management is routine for all adult ECMO patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Gillian Radcliffe, +447966 123385, Gill.Radcliffe@nhs.net
About this study
Official title: Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation (ECMO) Patients
Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.
A sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.
Read more
However, there are no protocols for giving sedation to ECMO patients in research papers. Investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.
Aims:
To see whether it is possible to run a trial that compares using a sedation protocol against usual care.
Design/methods:
Thirty to 60 ECMO patients will be chosen and will be put into one of two groups. One group will receive usual care, and the other will receive care using the sedation protocol. The investigators will collect information from both groups to find out if the study design works and how many patients agree to take part.
Patient and public involvement/engagement:
The investigators received feedback from patients and family member participants which helped to design this proposal, the lay summary and what to measure in a trial. They will advise how the investigators should review study findings, and support sharing of results to the public.
Impact/dissemination:
The investigators will share findings through social media, patient charities, research papers and conferences.
Read the detailed description
Research questions
- Is a cluster randomised controlled trial (cRCT) of a co-designed analgosedation protocol for adult ECMO patients feasible to conduct in terms of intervention delivery and data collection?
- What are the barriers and facilitators to the conduct of a cRCT of a co-designed analgosedation protocol?
STUDY AIM AND OBJECTIVES Overall aim and purpose • The overall aim is to test the feasibility of a cRCT of a co-designed analgosedation protocol for use with adult extracorporeal membrane oxygenation (ECMO) patients.
Objectives
Overall objective
- To evaluate the feasibility of a cRCT of a co-designed analgosedation protocol for ECMO patients in terms of intervention delivery and data collection. This will inform the design of a future adequately powered cRCT.
Feasibility objectives
- To assess fidelity of intervention delivery (adherence to the study protocol)
- To establish barriers and facilitators to trial conduct and intervention delivery
- To assess the feasibility of data collection methods
- To assess the acceptability of the co-designed analgosedation protocol from the perspectives of nursing, medical, and pharmacy staff using it.
Exploratory clinical objectives include
- Duration of mechanical ventilation
- Occurrence, and duration of delirium (days)
- Duration of ECMO treatment
- Daily analgosedation doses (enteral and intravenous opioids and sedatives)
- Average Pain (Critical Care Pain Observation Tool - CPOT), sedation (Richmond Agitation and Sedation Scale - RASS) and delirium (Confusion Assessment Method for the Intensive Care Unit - CAM-ICU) scores
- ICU and hospital length of stay
- ICU and hospital mortality
- Accidental removal of the endotracheal tube
- Accidental removal of other tubes and invasive lines
- Use of physical restraints
STUDY DESIGN
The investigators will conduct a feasibility cRCT in two tertiary adult ECMO centres within Guy's \& St Thomas' NHS Foundation Trust (St Thomas' Hospital (cluster 1) and Royal Brompton Hospital (cluster 2)). The investigators have chosen a cRCT study design to reduce intervention contamination by healthcare professional participants delivering care in the intervention or control arms. This is important to ensure all patients within the same cluster receive the same treatment.
Study procedures
Control arm: Will comprise the standard of care for delivery of analgosedation and all other medical treatment while in the ICU. Standard of care includes use of pain (Critical-Care Pain Observation Tool - CPOT), and sedation (Richmond Agitation and Sedation Scale - RASS) scores to assess pain and sedation levels, and the use of opioids and sedatives to keep patients comfortable and pain-free with drug type and dosing selected by the ICU clinical team. One cluster (ICU) will be randomly assigned to this arm.
Intervention arm: Will comprise the use of the previously co-designed analgosedation protocol. The analgosedation protocol will focus on setting a daily target for pain using the CPOT score, and sedation using the RASS score. The protocol will include recommended opioid and sedative medicines and their dose ranges, guidance on titration of opioid and sedative doses based on pain and sedation scores, daily interruption of sedation, use of non-pharmacological approaches to keep patients calm and to promote sleep, and methods of weaning opioids and sedatives. Patients will also be assessed daily for delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). All other treatments will be as per standard care and at the discretion of the treating clinical team. The sedation protocol will be used for up to 10 days after commencement of ECMO. One cluster (ICU) will be randomly assigned to this arm.
Randomisation and blinding
The ECMO unit will be the unit of randomisation, with patients allocated to treatment or control according to their assigned cluster. Participants will be included if they meet the inclusion criteria. Randomisation will be performed via the Sealed Envelope online randomisation module following ethics approval to provide enough time to organise staff training on the use of the protocol. Each cluster will be informed ahead of time as to which arm they will be allocated to for the purposes of training on the protocol. Given the nature of the intervention, neither the treating clinicians, patients, nor data collectors can be blinded. However, exploratory outcome measures are objective and documented in the patient's medical record.
Staff training on the use of the protocol
Healthcare professionals (doctors, nurses and pharmacists) will receive training from the research team on the use of the protocol prior to the study launching and during trial recruitment in the centre allocated to the intervention arm. The investigators will provide training (in-person and virtually) on elements of the trial protocol, including analgosedation dose titration, targeted Richmond Agitation and Sedation Scale (RASS) scores, and the duration of protocol use. The investigators will also provide refresher training to staff in both arms of the study on the use of CPOT, RASS, and CAM-ICU assessments. A training log will be used to determine who has been trained and the date of training.
Success criteria
The investigators will assess the following criteria to inform progression to seeking funding for a future cRCT.
Progression criteria
- Adherence to the protocol as intended.
- Acceptability of the protocol by staff delivering the intervention.
The investigators will use a traffic light system to guide progression criteria as recommended in best practice guidelines.
Green: Progress to apply for trial funding, with review of screening logs and protocol revision to address any barriers to recruitment and delivery of the intervention.
Amber: Consider progression to apply for trial funding with consultation with key stakeholders, review of screening logs, and protocol revision to address any barriers to recruitment, delivery of the intervention and harness facilitators.
Red: Unable to progress to trial funding application.
Assessment of protocol adherence
The investigators will assess protocol adherence daily using a fidelity checklist. Adherence to the protocol will be deemed good if 70% of daily fidelity checklist items have been met over the study period.
- Daily RASS target recorded in electronic health record
- RASS score recorded in electronic health record at least once per 12-hour nursing shift
- CPOT behavioural pain score recorded in electronic health record at least once per 12-hour nursing shift
- Delirium screen (CAM-ICU) recorded in electronic health record if RASS >-3
- Fentanyl used as continuous opioid infusion
- Fentanyl continuous infusion dose within recommended range over the 24 hours
- Propofol and/or midazolam used as continuous infusion sedative
- Propofol and/or midazolam continuous infusion dose within recommended range over the 24 hours
Assessment of acceptability of the protocol
Staff participants will complete the validated Acceptability of Intervention Measure (AIM)/Feasibility of Intervention Measure (FIM) questionnaires and will be offered the opportunity to participate in an interview. The questionnaire will include questions including whether the analgosedation protocol meets staff approval and is appealing for ECMO patients, and if it is liked and welcomed for use in clinical practice. The AIM/FIM questionnaire will be administered daily to staff, who have used the protocol, before they go home after their day or night shift. The investigators will use codes to track if staff have answered the AIM questionnaire more than once during the study period. The analgosedation protocol will be deemed acceptable if all participants rated the acceptability questions as a mark of 4 (agree) or 5 (completely agree) in 70% of cases across all completed questionnaires.
Fidelity
The investigators will use the Theoretical Domains Framework (TDF) to guide both the measurement of fidelity and to understand factors affecting trial delivery. The progression criteria for protocol adherence are based on at least a 70% fidelity rate in line with a previous study.
Data to be collected
Feasibility and fidelity trial data
The direct care team will enter de-identified data on to the electronic case report form (e-CRF). The investigators will develop an e-CRF to collect de-identified patient demographic characteristics, analgosedation management and patient outcomes in the intervention and control arms. The investigators will develop an additional e-CRF to allow the collection of feasibility data (assessment of protocol adherence). The research team will enter de-identified data to the electronic data capture system (REDCap). This is to ensure participant confidentiality. The investigators will ensure a delegation log is completed.
Data collected will include baseline characteristics and severity scores (age, gender, height, weight, body mass index, worst documented PaO2/FiO2 (P/F) ratio prior to ECMO cannulation, APACHE II scores, admission SOFA scores, admission C-reactive protein, pregnancy or postpartum, ECMO modality, primary reason for ECMO, admission type, past medical history), and exploratory clinical objectives from the patient's medical notes. The research team will record all patients who were enrolled into the study using a Site Master Log sheet and Screening Log, and record any concerns relating to the intervention. The investigators will collect sedation data up to 10 days for the intervention and control arms.
The investigators will collect data on intervention fidelity at the site using the sedation protocol using the fidelity checklist.
The investigators will conduct semi-structured interviews online via Microsoft Teams with staff participants to explore their perceptions of barriers and facilitators to use of the co-designed sedation protocol and their views on its acceptability during the feasibility trial. The investigators will use a interview guide and a questionnaire, which will be based on the TDF and the AIM/FIM Questionnaire. The investigators will use purposive sampling (based on years of ICU experience and the number of patient participants they have managed using the protocol) to interview doctors, nurses, and pharmacists involved in protocol delivery. The investigators will collect basic demographic characteristics, professional role, years of ICU experience. All interviews will be digitally recorded and transcribed by a professional transcription company.
Data analysis
Quantitative analysis
Fidelity analysis
The investigators will sum the scores of the daily checklist to a maximum score of 8 (if an item on the checklist is ticked yes, a score of 1 is added). The investigators will average the scores of all the daily checklists completed per patient during study enrolment. Protocol adherence will be defined as at least 70% of the daily checklist score.
Acceptability questionnaire analysis
The investigators will review all completed AIM/FIM questionnaires and if at least 70% of responses are recorded as 4 (agree) or 5 (completely agree), acceptability will be achieved.
Exploratory patient outcomes
The investigators will calculate the mean (standard deviation) and median (interquartile range) of duration of mechanical ventilation, occurrence and duration of delirium, duration of ECMO, daily (24-hour period) dose of each analgosedation drug, ICU and hospital length of stay, and ICU and hospital mortality. The investigators will also calculate counts (%) for occurrence of delirium, accidental removal of the endotracheal tube, accidental removal of other tubes and invasive lines, and use of physical restraints. The investigators will convert all opioids (enteral and intravenous) to morphine dose equivalents; benzodiazepines (enteral and intravenous) into midazolam dose equivalents using opioid and benzodiazepine conversion tables (47,48). The investigators will calculate daily doses by dividing the sum of all analgosedation doses received during the data collection period by the number of days of collected data. Data will be analysed using R Studio.
Qualitative analysis
To analyse data on barriers, facilitators and acceptability, the investigators will use the Framework Method informed by the AIM/FIM Questionnaire and Theoretical Domains Framework (TDF). The investigators will dual-code transcripts coding data within the domains of the TFA and the TDF. The investigators will group and mark codes from the transcripts with one or more short descriptors to organise the raw data. The codes will then be grouped, summarised and categorised within the framework. The investigators will use NVIVO to support the coding and the analysis of the qualitative data.
- Conditions
- Intensive Care (ICU), Respiratory Distress Syndrome (RDS), Sedation and Analgesia, Extracorporeal Membrane Oxygenation, Sedation for Mechanical Ventilation, Cardiogenic Shock
- Being tested
- Sedation protocol
- Keywords
- extracorporeal membrane oxygenation, sedation, opioid, sedative, analgosedation, mechanical ventilation, ECMO, ICU, Intensive Care Unit, Critical Care, sedation protocol, analgesia
- Medical subject headings
- Respiratory Distress Syndrome, Agnosia, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation protocolOther
Also called Analgosedation protocol
Will comprise the use of the previously co-designed analgosedation protocol. The analgosedation protocol will focus on setting a daily target for pain using the CPOT score, and sedation using the RASS score. The protocol will include recommended opioid and sedative medicines and their dose ranges, guidance on titration of opioid and sedative doses based on pain and sedation scores, daily interruption of sedation, use of non-pharmacological approaches to keep patients calm and to promote sleep, and methods of weaning opioids and sedatives. Patients will also be assessed daily for delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). All other treatments will be as per standard care and at the discretion of the treating clinical team. The sedation protocol will be used for up to 10 days after commencement of ECMO. One cluster (ICU) will be randomly assigned to this arm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm - use of sedation protocol | Other | The analgosedation protocol will focus on setting a daily target for pain using the CPOT score, and sedation using the RASS score. The protocol will include recommended opioid and sedative medicines and their dose ranges, guidance on titration of opioid and sedative doses based on pain and sedation scores, daily interruption of sedation, use of non-pharmacological approaches to keep patients calm and to promote sleep, and methods of weaning opioids and sedatives. Patients will also be assessed daily for delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). All other treatments will be as per standard care and at the discretion of the treating clinical team. The sedation protocol will be used for up to 10 days after commencement of ECMO. One cluster (ICU) will be randomly assigned to this arm. Receives: Other: Sedation protocol |
| Standard of care for delivery of analgosedation and all other medical treatment while in the ICU | No intervention | Will comprise the standard of care for delivery of analgosedation and all other medical treatment while in the ICU. Standard of care includes use of pain (Critical-Care Pain Observation Tool - CPOT), and sedation (Richmond Agitation and Sedation Scale - RASS) scores to assess pain and sedation levels, and the use of opioids and sedatives to keep patients comfortable and pain-free with drug type and dosing selected by the ICU clinical team. One cluster (ICU) will be randomly assigned to this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of protocolised sedation
Ability to;
- Assess fidelity of intervention delivery (adherence to the study protocol)
- Establish barriers and facilitators to trial conduct and intervention delivery
- Assess the feasibility of data collection methods
- Assess the acceptability of the co-designed analgosedation protocol from the perspectives of nursing, medical, and pharmacy staff using it.
Measured: From date of randomisation to the end of treatment at 10 days, assessed up to 10 days
Secondary outcomes (13)
Duration of mechanical ventilation
Defined as time from randomisation until first successful unassisted breathing (no inspiratory support for 48hrs or ECMO) or death or hospital discharge (at recruiting site). Mean or median time in hours.
Measured: Defined as date of randomisation until first successful unassisted breathing (no inspiratory support for 48hrs or ECMO) or death or hospital discharge (at recruiting site), assessed up to 30 days. Censor at hospital discharge in recruiting centre.
Occurrence and duration of delirium
Occurrence and duration of delirium
Measured: From date of randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Duration of ECMO treatment
Number of days of ECMO treatment from start date to finish date of ECMO
Measured: From date of randomisation to ECMO decannulation, assessed up 30 days.
Daily morphine equivalent doses
Total doses of enteral and intravenous opioids
Measured: From date of randomisation to 10 days or death/transfer if occurs first, assessed up to 10 days.
Daily midazolam equivalent doses
Total enteral and intravenous benzodiazepine doses
Measured: From date of randomisation to 10 days or death/transfer if occurs first, assessed up to 10 days.
Daily propofol doses
Total propofol doses
Measured: From date of randomisation to 10 days or death/transfer if if occurs first, assessed up to 10 days.
ICU length of stay
Duration of stay in ICU (days) in recruiting centre
Measured: From date of randomisation to end of stay in ICU in recruiting centre, assessed up to 30 days.
Hospital length of stay
Duration of stay in hospital (days) in recruiting centre
Measured: From date of randomisation to end of stay in hospital in recruiting centre, assessed up to 30 days.
ICU mortality
Death in ICU in recruiting centre
Measured: From date of randomisation to death in ICU in recruiting centre, assessed up to 30 days.
Hospital mortality
Death in hospital of recruiting centre
Measured: From date of randomisation to death in hospital in recruiting centre, assessed up to 30 days.
Accidental removal of the endotracheal tube
Removal of endotracheal tube by patient during protocolised sedation
Measured: From date of randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Accidental removal of other tubes and invasive lines
Removal of other tubes and invasive lines by patient during protocolised sedation
Measured: From date of randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Use of physical restraints
Use of physical restraints during protocolised sedation
Measured: From randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Intensive Care (ICU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility cluster randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Louise Rose, PhD, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580781
- Sponsor's protocol ID
- IRAS number: 354798
- Other IDs
- NIHR304092
- Acronym
- ECMO-SED
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The King's Open Research Data System (KORDS) at King's College London will be used as a data repository, which will provide long-term storage and access for anonymised data and study protocol at project-end and to support publications. KORDS uses the Figshare data repository platform, providing a simple, self-deposit way for researchers to upload and share their data, and a publicly accessible showcase of datasets from King's research. It supports Open Research, enabling researchers to make datasets discoverable, accessible and citeable. All datasets have a DOI and a structured metadata record so that they can be shared and cited when re-used. Depositing meets the policy requirements of funders for data retention and sharing, and the requirements of many publishers for access to datasets supporting publications.
Publications
Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346. Epub 2012 Nov 20.
PubMed 23185138Blackwood B, Tume LN, Morris KP, Clarke M, McDowell C, Hemming K, Peters MJ, McIlmurray L, Jordan J, Agus A, Murray M, Parslow R, Walsh TS, Macrae D, Easter C, Feltbower RG, McAuley DF; SANDWICH Collaborators. Effect of a Sedation and Ventilator Liberation Protocol vs Usual Care on Duration of Invasive Mechanical Ventilation in Pediatric Intensive Care Units: A Randomized Clinical Trial. JAMA. 2021 Aug 3;326(5):401-410. doi: 10.1001/jama.2021.10296.
PubMed 34342620Blackwood B, Agus A, Boyle R, Clarke M, Hemming K, Jordan J, Macrae D, McAuley DF, McDowell C, McIlmurray L, Morris KP, Murray M, Parslow R, Peters MJ, Tume LN, Walsh T; Paediatric Intensive Care Society Study Group (PICS-SG). Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial. BMJ Open. 2019 Nov 10;9(11):e031630. doi: 10.1136/bmjopen-2019-031630.
PubMed 31712342Nix HP, Weijer C, Brehaut JC, Forster D, Goldstein CE, Taljaard M. Informed consent in cluster randomised trials: a guide for the perplexed. BMJ Open. 2021 Sep 27;11(9):e054213. doi: 10.1136/bmjopen-2021-054213.
PubMed 34580104Sim J, Dawson A. Informed consent and cluster-randomized trials. Am J Public Health. 2012 Mar;102(3):480-5. doi: 10.2105/AJPH.2011.300389. Epub 2012 Jan 19.
PubMed 22390511Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
PubMed 24993581Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
PubMed 22530986Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15. doi: 10.1097/00003246-199912000-00001.
PubMed 10628598Mahmoud L, Zullo AR, Thompson BB, Wendell LC. Outcomes of protocolised analgesia and sedation in a neurocritical care unit. Brain Inj. 2018;32(7):941-947. doi: 10.1080/02699052.2018.1469167. Epub 2018 Apr 30.
PubMed 29708438Rose L, Fitzgerald E, Cook D, Kim S, Steinberg M, Devlin JW, Ashley BJ, Dodek P, Smith O, Poretta K, Lee Y, Burns K, Harvey J, Skrobik Y, Fergusson D, Meade M, Kraguljac A, Burry L, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Clinician perspectives on protocols designed to minimize sedation. J Crit Care. 2015 Apr;30(2):348-52. doi: 10.1016/j.jcrc.2014.10.021. Epub 2014 Oct 30.
PubMed 25466317Rose RL, Bucknall T. Staff perceptions on the use of a sedation protocol in the intensive care setting. Aust Crit Care. 2004 Nov;17(4):151-9. doi: 10.1016/s1036-7314(04)80020-1.
PubMed 18038524Shehabi Y, Bellomo R, Kadiman S, Ti LK, Howe B, Reade MC, Khoo TM, Alias A, Wong YL, Mukhopadhyay A, McArthur C, Seppelt I, Webb SA, Green M, Bailey MJ; Sedation Practice in Intensive Care Evaluation (SPICE) Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Sedation Intensity in the First 48 Hours of Mechanical Ventilation and 180-Day Mortality: A Multinational Prospective Longitudinal Cohort Study. Crit Care Med. 2018 Jun;46(6):850-859. doi: 10.1097/CCM.0000000000003071.
PubMed 29498938Stephens RJ, Dettmer MR, Roberts BW, Ablordeppey E, Fowler SA, Kollef MH, Fuller BM. Practice Patterns and Outcomes Associated With Early Sedation Depth in Mechanically Ventilated Patients: A Systematic Review and Meta-Analysis. Crit Care Med. 2018 Mar;46(3):471-479. doi: 10.1097/CCM.0000000000002885.
PubMed 29227367Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
PubMed 10816184Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation (ECMO) Patients
- ClinicalTrials.gov ID
- NCT07580781
- Acronym / sponsor ID
- ECMO-SED / IRAS number: 354798
- Conditions
- Intensive Care (ICU), Respiratory Distress Syndrome (RDS), Sedation and Analgesia, Extracorporeal Membrane Oxygenation, Sedation for Mechanical Ventilation, Cardiogenic Shock
- Keywords
- extracorporeal membrane oxygenation, sedation, opioid, sedative, analgosedation, mechanical ventilation, ECMO, ICU
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.
A sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.
However, there are no protocols for giving sedation to ECMO patients in research papers. Investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.
Aims:
To see whether it is possible to run a trial that compares using a sedation protocol against usual care.
Design/methods:
Thirty to 60 ECMO patients will be chosen and will be put into one of two groups. One group will receive usual care, and the other will receive care using the sedation protocol. The investigators will collect information from both groups to find out if the study design works and how many patients agree to take part.
Patient and public involvement/engagement:
The investigators received feedback from patients and family member participants which helped to design this proposal, the lay summary and what to measure in a trial. They will advise how the investigators should review study findings, and support sharing of results to the public.
Impact/dissemination:
The investigators will share findings through social media, patient charities, research papers and conferences.
Detailed description
Research questions
- Is a cluster randomised controlled trial (cRCT) of a co-designed analgosedation protocol for adult ECMO patients feasible to conduct in terms of intervention delivery and data collection?
- What are the barriers and facilitators to the conduct of a cRCT of a co-designed analgosedation protocol?
STUDY AIM AND OBJECTIVES Overall aim and purpose • The overall aim is to test the feasibility of a cRCT of a co-designed analgosedation protocol for use with adult extracorporeal membrane oxygenation (ECMO) patients.
Objectives
Overall objective
- To evaluate the feasibility of a cRCT of a co-designed analgosedation protocol for ECMO patients in terms of intervention delivery and data collection. This will inform the design of a future adequately powered cRCT.
Feasibility objectives
- To assess fidelity of intervention delivery (adherence to the study protocol)
- To establish barriers and facilitators to trial conduct and intervention delivery
- To assess the feasibility of data collection methods
- To assess the acceptability of the co-designed analgosedation protocol from the perspectives of nursing, medical, and pharmacy staff using it.
Exploratory clinical objectives include
- Duration of mechanical ventilation
- Occurrence, and duration of delirium (days)
- Duration of ECMO treatment
- Daily analgosedation doses (enteral and intravenous opioids and sedatives)
- Average Pain (Critical Care Pain Observation Tool - CPOT), sedation (Richmond Agitation and Sedation Scale - RASS) and delirium (Confusion Assessment Method for the Intensive Care Unit - CAM-ICU) scores
- ICU and hospital length of stay
- ICU and hospital mortality
- Accidental removal of the endotracheal tube
- Accidental removal of other tubes and invasive lines
- Use of physical restraints
STUDY DESIGN
The investigators will conduct a feasibility cRCT in two tertiary adult ECMO centres within Guy's \& St Thomas' NHS Foundation Trust (St Thomas' Hospital (cluster 1) and Royal Brompton Hospital (cluster 2)). The investigators have chosen a cRCT study design to reduce intervention contamination by healthcare professional participants delivering care in the intervention or control arms. This is important to ensure all patients within the same cluster receive the same treatment.
Study procedures
Control arm: Will comprise the standard of care for delivery of analgosedation and all other medical treatment while in the ICU. Standard of care includes use of pain (Critical-Care Pain Observation Tool - CPOT), and sedation (Richmond Agitation and Sedation Scale - RASS) scores to assess pain and sedation levels, and the use of opioids and sedatives to keep patients comfortable and pain-free with drug type and dosing selected by the ICU clinical team. One cluster (ICU) will be randomly assigned to this arm.
Intervention arm: Will comprise the use of the previously co-designed analgosedation protocol. The analgosedation protocol will focus on setting a daily target for pain using the CPOT score, and sedation using the RASS score. The protocol will include recommended opioid and sedative medicines and their dose ranges, guidance on titration of opioid and sedative doses based on pain and sedation scores, daily interruption of sedation, use of non-pharmacological approaches to keep patients calm and to promote sleep, and methods of weaning opioids and sedatives. Patients will also be assessed daily for delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). All other treatments will be as per standard care and at the discretion of the treating clinical team. The sedation protocol will be used for up to 10 days after commencement of ECMO. One cluster (ICU) will be randomly assigned to this arm.
Randomisation and blinding
The ECMO unit will be the unit of randomisation, with patients allocated to treatment or control according to their assigned cluster. Participants will be included if they meet the inclusion criteria. Randomisation will be performed via the Sealed Envelope online randomisation module following ethics approval to provide enough time to organise staff training on the use of the protocol. Each cluster will be informed ahead of time as to which arm they will be allocated to for the purposes of training on the protocol. Given the nature of the intervention, neither the treating clinicians, patients, nor data collectors can be blinded. However, exploratory outcome measures are objective and documented in the patient's medical record.
Staff training on the use of the protocol
Healthcare professionals (doctors, nurses and pharmacists) will receive training from the research team on the use of the protocol prior to the study launching and during trial recruitment in the centre allocated to the intervention arm. The investigators will provide training (in-person and virtually) on elements of the trial protocol, including analgosedation dose titration, targeted Richmond Agitation and Sedation Scale (RASS) scores, and the duration of protocol use. The investigators will also provide refresher training to staff in both arms of the study on the use of CPOT, RASS, and CAM-ICU assessments. A training log will be used to determine who has been trained and the date of training.
Success criteria
The investigators will assess the following criteria to inform progression to seeking funding for a future cRCT.
Progression criteria
- Adherence to the protocol as intended.
- Acceptability of the protocol by staff delivering the intervention.
The investigators will use a traffic light system to guide progression criteria as recommended in best practice guidelines.
Green: Progress to apply for trial funding, with review of screening logs and protocol revision to address any barriers to recruitment and delivery of the intervention.
Amber: Consider progression to apply for trial funding with consultation with key stakeholders, review of screening logs, and protocol revision to address any barriers to recruitment, delivery of the intervention and harness facilitators.
Red: Unable to progress to trial funding application.
Assessment of protocol adherence
The investigators will assess protocol adherence daily using a fidelity checklist. Adherence to the protocol will be deemed good if 70% of daily fidelity checklist items have been met over the study period.
- Daily RASS target recorded in electronic health record
- RASS score recorded in electronic health record at least once per 12-hour nursing shift
- CPOT behavioural pain score recorded in electronic health record at least once per 12-hour nursing shift
- Delirium screen (CAM-ICU) recorded in electronic health record if RASS >-3
- Fentanyl used as continuous opioid infusion
- Fentanyl continuous infusion dose within recommended range over the 24 hours
- Propofol and/or midazolam used as continuous infusion sedative
- Propofol and/or midazolam continuous infusion dose within recommended range over the 24 hours
Assessment of acceptability of the protocol
Staff participants will complete the validated Acceptability of Intervention Measure (AIM)/Feasibility of Intervention Measure (FIM) questionnaires and will be offered the opportunity to participate in an interview. The questionnaire will include questions including whether the analgosedation protocol meets staff approval and is appealing for ECMO patients, and if it is liked and welcomed for use in clinical practice. The AIM/FIM questionnaire will be administered daily to staff, who have used the protocol, before they go home after their day or night shift. The investigators will use codes to track if staff have answered the AIM questionnaire more than once during the study period. The analgosedation protocol will be deemed acceptable if all participants rated the acceptability questions as a mark of 4 (agree) or 5 (completely agree) in 70% of cases across all completed questionnaires.
Fidelity
The investigators will use the Theoretical Domains Framework (TDF) to guide both the measurement of fidelity and to understand factors affecting trial delivery. The progression criteria for protocol adherence are based on at least a 70% fidelity rate in line with a previous study.
Data to be collected
Feasibility and fidelity trial data
The direct care team will enter de-identified data on to the electronic case report form (e-CRF). The investigators will develop an e-CRF to collect de-identified patient demographic characteristics, analgosedation management and patient outcomes in the intervention and control arms. The investigators will develop an additional e-CRF to allow the collection of feasibility data (assessment of protocol adherence). The research team will enter de-identified data to the electronic data capture system (REDCap). This is to ensure participant confidentiality. The investigators will ensure a delegation log is completed.
Data collected will include baseline characteristics and severity scores (age, gender, height, weight, body mass index, worst documented PaO2/FiO2 (P/F) ratio prior to ECMO cannulation, APACHE II scores, admission SOFA scores, admission C-reactive protein, pregnancy or postpartum, ECMO modality, primary reason for ECMO, admission type, past medical history), and exploratory clinical objectives from the patient's medical notes. The research team will record all patients who were enrolled into the study using a Site Master Log sheet and Screening Log, and record any concerns relating to the intervention. The investigators will collect sedation data up to 10 days for the intervention and control arms.
The investigators will collect data on intervention fidelity at the site using the sedation protocol using the fidelity checklist.
The investigators will conduct semi-structured interviews online via Microsoft Teams with staff participants to explore their perceptions of barriers and facilitators to use of the co-designed sedation protocol and their views on its acceptability during the feasibility trial. The investigators will use a interview guide and a questionnaire, which will be based on the TDF and the AIM/FIM Questionnaire. The investigators will use purposive sampling (based on years of ICU experience and the number of patient participants they have managed using the protocol) to interview doctors, nurses, and pharmacists involved in protocol delivery. The investigators will collect basic demographic characteristics, professional role, years of ICU experience. All interviews will be digitally recorded and transcribed by a professional transcription company.
Data analysis
Quantitative analysis
Fidelity analysis
The investigators will sum the scores of the daily checklist to a maximum score of 8 (if an item on the checklist is ticked yes, a score of 1 is added). The investigators will average the scores of all the daily checklists completed per patient during study enrolment. Protocol adherence will be defined as at least 70% of the daily checklist score.
Acceptability questionnaire analysis
The investigators will review all completed AIM/FIM questionnaires and if at least 70% of responses are recorded as 4 (agree) or 5 (completely agree), acceptability will be achieved.
Exploratory patient outcomes
The investigators will calculate the mean (standard deviation) and median (interquartile range) of duration of mechanical ventilation, occurrence and duration of delirium, duration of ECMO, daily (24-hour period) dose of each analgosedation drug, ICU and hospital length of stay, and ICU and hospital mortality. The investigators will also calculate counts (%) for occurrence of delirium, accidental removal of the endotracheal tube, accidental removal of other tubes and invasive lines, and use of physical restraints. The investigators will convert all opioids (enteral and intravenous) to morphine dose equivalents; benzodiazepines (enteral and intravenous) into midazolam dose equivalents using opioid and benzodiazepine conversion tables (47,48). The investigators will calculate daily doses by dividing the sum of all analgosedation doses received during the data collection period by the number of days of collected data. Data will be analysed using R Studio.
Qualitative analysis
To analyse data on barriers, facilitators and acceptability, the investigators will use the Framework Method informed by the AIM/FIM Questionnaire and Theoretical Domains Framework (TDF). The investigators will dual-code transcripts coding data within the domains of the TFA and the TDF. The investigators will group and mark codes from the transcripts with one or more short descriptors to organise the raw data. The codes will then be grouped, summarised and categorised within the framework. The investigators will use NVIVO to support the coding and the analysis of the qualitative data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm - use of sedation protocol | Other | Other: Sedation protocolThe analgosedation protocol will focus on setting a daily target for pain using the CPOT score, and sedation using the RASS score. The protocol will include recommended opioid and sedative medicines and their dose ranges, guidance on titration of opioid and sedative doses based on pain and sedation scores, daily interruption of sedation, use of non-pharmacological approaches to keep patients calm and to promote sleep, and methods of weaning opioids and sedatives. Patients will also be assessed daily for delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). All other treatments will be as per standard care and at the discretion of the treating clinical team. The sedation protocol will be used for up to 10 days after commencement of ECMO. One cluster (ICU) will be randomly assigned to this arm. |
| Standard of care for delivery of analgosedation and all other medical treatment while in the ICU | No intervention | –Will comprise the standard of care for delivery of analgosedation and all other medical treatment while in the ICU. Standard of care includes use of pain (Critical-Care Pain Observation Tool - CPOT), and sedation (Richmond Agitation and Sedation Scale - RASS) scores to assess pain and sedation levels, and the use of opioids and sedatives to keep patients comfortable and pain-free with drug type and dosing selected by the ICU clinical team. One cluster (ICU) will be randomly assigned to this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years and older
- Receiving IV continuous infusions of analgosedation medication
- Receiving ECMO treatment
Key exclusion criteria (1 listed)
- There will be no exclusion criteria as analgosedation management is routine for all adult ECMO patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation protocolAlso: Analgosedation protocolWill comprise the use of the previously co-designed analgosedation protocol. The analgosedation protocol will focus on setting a daily target for pain using the CPOT score, and sedation using the RASS score. The protocol will include recommended opioid and sedative medicines and their dose ranges, guidance on titration of opioid and sedative doses based on pain and sedation scores, daily interruption of sedation, use of non-pharmacological approaches to keep patients calm and to promote sleep, and methods of weaning opioids and sedatives. Patients will also be assessed daily for delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). All other treatments will be as per standard care and at the discretion of the treating clinical team. The sedation protocol will be used for up to 10 days after commencement of ECMO. One cluster (ICU) will be randomly assigned to this arm. | Other | Intervention arm - use of sedation protocol |
Primary outcome
Feasibility of protocolised sedation
Time frame: From date of randomisation to the end of treatment at 10 days, assessed up to 10 days
Ability to; 1. Assess fidelity of intervention delivery (adherence to the study protocol) 2. Establish barriers and facilitators to trial conduct and intervention delivery 3. Assess the feasibility of data collection methods 4. Assess the acceptability of the co-designed analgosedation protocol from the perspectives of nursing, medical, and pharmacy staff using it.
13 secondary outcomes
Duration of mechanical ventilation
Time frame: Defined as date of randomisation until first successful unassisted breathing (no inspiratory support for 48hrs or ECMO) or death or hospital discharge (at recruiting site), assessed up to 30 days. Censor at hospital discharge in recruiting centre.
Occurrence and duration of delirium
Time frame: From date of randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Duration of ECMO treatment
Time frame: From date of randomisation to ECMO decannulation, assessed up 30 days.
Daily morphine equivalent doses
Time frame: From date of randomisation to 10 days or death/transfer if occurs first, assessed up to 10 days.
Daily midazolam equivalent doses
Time frame: From date of randomisation to 10 days or death/transfer if occurs first, assessed up to 10 days.
Daily propofol doses
Time frame: From date of randomisation to 10 days or death/transfer if if occurs first, assessed up to 10 days.
ICU length of stay
Time frame: From date of randomisation to end of stay in ICU in recruiting centre, assessed up to 30 days.
Hospital length of stay
Time frame: From date of randomisation to end of stay in hospital in recruiting centre, assessed up to 30 days.
ICU mortality
Time frame: From date of randomisation to death in ICU in recruiting centre, assessed up to 30 days.
Hospital mortality
Time frame: From date of randomisation to death in hospital in recruiting centre, assessed up to 30 days.
Accidental removal of the endotracheal tube
Time frame: From date of randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Accidental removal of other tubes and invasive lines
Time frame: From date of randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Use of physical restraints
Time frame: From randomisation to 10 days or death or transfer if occurs first, assessed up to 10 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 23185138Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346. Epub 2012 Nov 20.
- Background: PubMed 34342620Blackwood B, Tume LN, Morris KP, Clarke M, McDowell C, Hemming K, Peters MJ, McIlmurray L, Jordan J, Agus A, Murray M, Parslow R, Walsh TS, Macrae D, Easter C, Feltbower RG, McAuley DF; SANDWICH Collaborators. Effect of a Sedation and Ventilator Liberation Protocol vs Usual Care on Duration of Invasive Mechanical Ventilation in Pediatric Intensive Care Units: A Randomized Clinical Trial. JAMA. 2021 Aug 3;326(5):401-410. doi: 10.1001/jama.2021.10296.
- Background: PubMed 31712342Blackwood B, Agus A, Boyle R, Clarke M, Hemming K, Jordan J, Macrae D, McAuley DF, McDowell C, McIlmurray L, Morris KP, Murray M, Parslow R, Peters MJ, Tume LN, Walsh T; Paediatric Intensive Care Society Study Group (PICS-SG). Sedation AND Weaning In Children (SANDWICH): protocol for a cluster randomised stepped wedge trial. BMJ Open. 2019 Nov 10;9(11):e031630. doi: 10.1136/bmjopen-2019-031630.
- Background: PubMed 34580104Nix HP, Weijer C, Brehaut JC, Forster D, Goldstein CE, Taljaard M. Informed consent in cluster randomised trials: a guide for the perplexed. BMJ Open. 2021 Sep 27;11(9):e054213. doi: 10.1136/bmjopen-2021-054213.
- Background: PubMed 22390511Sim J, Dawson A. Informed consent and cluster-randomized trials. Am J Public Health. 2012 Mar;102(3):480-5. doi: 10.2105/AJPH.2011.300389. Epub 2012 Jan 19.
- Background: PubMed 24993581Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
- Background: PubMed 22530986Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
- Background: PubMed 10628598Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15. doi: 10.1097/00003246-199912000-00001.
- Background: PubMed 29708438Mahmoud L, Zullo AR, Thompson BB, Wendell LC. Outcomes of protocolised analgesia and sedation in a neurocritical care unit. Brain Inj. 2018;32(7):941-947. doi: 10.1080/02699052.2018.1469167. Epub 2018 Apr 30.
- Background: PubMed 25466317Rose L, Fitzgerald E, Cook D, Kim S, Steinberg M, Devlin JW, Ashley BJ, Dodek P, Smith O, Poretta K, Lee Y, Burns K, Harvey J, Skrobik Y, Fergusson D, Meade M, Kraguljac A, Burry L, Mehta S; SLEAP Investigators; Canadian Critical Care Trials Group. Clinician perspectives on protocols designed to minimize sedation. J Crit Care. 2015 Apr;30(2):348-52. doi: 10.1016/j.jcrc.2014.10.021. Epub 2014 Oct 30.
- Background: PubMed 18038524Rose RL, Bucknall T. Staff perceptions on the use of a sedation protocol in the intensive care setting. Aust Crit Care. 2004 Nov;17(4):151-9. doi: 10.1016/s1036-7314(04)80020-1.
- Background: PubMed 29498938Shehabi Y, Bellomo R, Kadiman S, Ti LK, Howe B, Reade MC, Khoo TM, Alias A, Wong YL, Mukhopadhyay A, McArthur C, Seppelt I, Webb SA, Green M, Bailey MJ; Sedation Practice in Intensive Care Evaluation (SPICE) Study Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Sedation Intensity in the First 48 Hours of Mechanical Ventilation and 180-Day Mortality: A Multinational Prospective Longitudinal Cohort Study. Crit Care Med. 2018 Jun;46(6):850-859. doi: 10.1097/CCM.0000000000003071.
- Individual participant dataSharing planned: Yes. The King's Open Research Data System (KORDS) at King's College London will be used as a data repository, which will provide long-term storage and access for anonymised data and study protocol at project-end and to support publications. KORDS uses the Figshare data repository platform, providing a simple, self-deposit way for researchers to upload and share their data, and a publicly accessible showcase of datasets from King's research. It supports Open Research, enabling researchers to make datasets discoverable, accessible and citeable. All datasets have a DOI and a structured metadata record so that they can be shared and cited when re-used. Depositing meets the policy requirements of funders for data retention and sharing, and the requirements of many publishers for access to datasets supporting publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise Rose, PhD study chair
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation protocol in people with Intensive Care (ICU) and Respiratory Distress Syndrome (RDS), run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Remmington, MPharm (+442078365454, christopher.remmington@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of protocolised sedation (time frame: From date of randomisation to the end of treatment at 10 days, assessed up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07580781, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.