Intensive Care Unit DeliriumDaCsi-ICUNCT06355570
Delirium After Cardiac Surgery in Intensive Care Units
A study testing Personal Pictures, Family Videos and Family Videos - Intervention as required in people with Intensive Care Unit Delirium and Cardiac Surgery, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
STUDY SUMMARY STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Delirium, Cardiac Surgery, Post Operative Delirium
- What is being tested?
- Personal Pictures, Family Videos and Family Videos - Intervention as required
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients
- Female and male patients over the age of 18
- Participants speaking English language and having mental capacity to consent
- Suitable to undergoing cardiac surgery at ICHT.
- Family Members/Friends
- Nominated by the participant.
Show all 9Show fewer
- Be willing to record videos and participate in the study.
- Healthcare professionals
- Critical Care Nurses that have provided direct care to at least one patient who received the study intervention
Who cannot join
- Patients
- Female and male patients under the age of 18
- Unable to consent to the study pre-operatively
- Significant hearing/visual impairment
- Participants with learning disabilities, pre-existing delirium, dementia or other significant underlying cognitive morbidity
- Moribund participants, likely to die in the next 24 hours
Show all 21Show fewer
- Participants that do not speak English language
- Family Members/Friends
- Refuse to consent or gain assent
- Significant hearing/visual impairment
- Family members/friends that do not speak English language
- Healthcare professionals
- Critical care nurses that have not been involved in the implementation of the intervention
- Refuse to consent or gain assent
- Significant hearing/visual impairment and non-English speaking
- WITHDRAWAL CRITERIA:
- Participants
- No longer willing to participate after consent
- Personal consultee wishing to withdraw participants from the study
- Patients that the clinical and/or research team deem too distressed to continue participating in the study
- Patients who have lost the capacity to participate in the study after hospital discharge
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0HS
Maria Reguenga, BSN, +442033131703, maria.reguenga@nhs.net
Sanooj Soni, PhD, 07714329708, sanooj.soni@nhs.net
About this study
Official title: The Use of Auditory-visual Stimulation to Reduce Delirium Rates in Intensive Care Patients Post-cardiac Surgery: a Feasibility Study
STUDY SUMMARY
STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). This study is a mixed methods research design that includes the collection of data through qualitative interviews, quality-of-life questionnaires and patients' medical records.
Read more
AIMS
- Determine the incidence of ICU delirium in ICHT following cardiac surgery
- Explore the compliance of outcome measures that diagnose ICU delirium
- Implement a family-focused sensory stimulation programme in the ICU
- Evaluate its useability and potential impact on patients, families and ICU staff
STUDY POPULATION 30 study participants (12 patients, 12 family members/friends and 6 ICU nurses)
ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).
DURATION 12 months at Hammersmith Hospital, ICHT
Read the detailed description
DaCsi-ICU is a mixed methods research study including the collection of data from patient's medical notes, interviews and quality of life questionnaires following the study schedule of assessments. This study also involves the implementation of an auditory-visual sensory stimulation package in the cardiac ICU at ICHT to participants enrolled in the study.
Digital photos will be shown continuously at the patient's bedside (8am-8pm) after cardiac surgery and will always have reference to time and date. Additionally, videos will be played throughout the patient's stay in the ICU at least three times per day (timepoints: 9am, 2pm,7pm) and upon participant request. Videos will be also played when participants show signs of ICU delirium to reduce its incidence and improve overall health outcomes. Simultaneously, data from patients' medical records will be routinely collected by the research team (e.g., Confusion Assessment Method-ICU, Richmond Agitation Sedation Scale, etc.) to assess whether patients develop delirium during their stay in the ICU.
Interviews with patients and families/friends will be held on three different occasions. The first one will be on the same day as ICU discharge, the second interview will be on the day of hospital discharge and the third one will be carried out up to a month following hospital discharge during their clinical follow-up appointment. Where possible, family members/friends and patient interviews will be conducted together (dyadic interviewing), but the possibility of performing interviews separately will be given so that participants feel able to discuss opinions freely. Nurses' interviews will be held as a one-off and after they have provided direct care to participants who received the proposed intervention.
Each patient will be followed up daily on the wards and once at the monthly follow-up clinic after ICU discharge, where cognitive and emotional assessments will be performed to evaluate delirium outcomes. The research team will also collect relevant information from participants' medical notes if any complications post-ICU discharge arise during inpatient and follow-up stages.
- Being tested
- Personal Pictures, Family Videos, Family Videos - Intervention as required
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal PicturesOther
Digital photos will be shown continuously at the patient's bedside for 12 hours a day (between 8 am to 8 pm).
Family VideosOther
Family-recorded videos will be played three times at specific hours of the day - 9 am, 2 pm and 7 pm - throughout patient stay in the ICU
Family Videos - Intervention as requiredOther
The last video shown will be re-played upon patient request and/or if patients develop ICU delirium.
| Study group | Role | What they receive |
|---|---|---|
| Patient Arm | Experimental | 12 patients will be recruited pre-operatively and submitted to the study intervention Receives: Other: Personal Pictures; Other: Family Videos; Other: Family Videos - Intervention as required |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing the study intervention
The investigators plan to implement a family-focused auditory-visual sensory stimulation intervention to reduce ICU delirium rates post-cardiac surgery. Feasibility will be assessed by exploring facilitator factors and challenges that may arise during the implementation of this intervention. These elements will be recorded on a study reflective log and further discussed within the study team.
Measured: 12 months
Secondary outcomes (3)
Practicalities of introducing the study intervention
The investigators intend to explore the practical aspects of implementing an innovative non-pharmacological intervention in cardiac surgical ICU. The investigators also aim to collect nursing checklists, routinely liaise with the local clinical/research team and explore any additional internal approvals to implement the study in the ICU.
Measured: 12 months
Acceptability of implementing the study intervention
The investigators plan to conduct qualitative interviews with critical care staff, patients and family members/friends to explore their acceptance and experience of taking part in the study.
Measured: 12 months
Short-term delirium outcomes post-ICU discharge
The investigators intend to conduct an extra qualitative interview with patients and family members/friends up to a month after hospital discharge to explore any post-ICU delirium complications. Additionally, cognitive and emotional questionnaires (The Mini-Mental State Examination, General Anxiety Disorder-7 and Patient Health Questionnaire-9) will be performed at two different time points to further explore post-ICU delirium outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start20 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit DeliriumStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12-patient participants will be submitted to the study intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Reguenga, BSN, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355570
- Sponsor's protocol ID
- 331314
- Other IDs
- RFPR2324_29, 24/YH/0011
- Acronym
- DaCsi-ICU
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Azinheira Reguenga MJ, Lampridou S, Pattison N, Brett SJ, Soni S. The use of audio-visual aids to reduce delirium after cardiac surgery in intensive care units (DaCSi-ICU): A feasibility study protocol. PLoS One. 2025 Apr 24;20(4):e0320935. doi: 10.1371/journal.pone.0320935. eCollection 2025.
PubMed 40273276
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Auditory-visual Stimulation to Reduce Delirium Rates in Intensive Care Patients Post-cardiac Surgery: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06355570
- Acronym / sponsor ID
- DaCsi-ICU / 331314
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
STUDY SUMMARY
STUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). This study is a mixed methods research design that includes the collection of data through qualitative interviews, quality-of-life questionnaires and patients' medical records.
AIMS
- Determine the incidence of ICU delirium in ICHT following cardiac surgery
- Explore the compliance of outcome measures that diagnose ICU delirium
- Implement a family-focused sensory stimulation programme in the ICU
- Evaluate its useability and potential impact on patients, families and ICU staff
STUDY POPULATION 30 study participants (12 patients, 12 family members/friends and 6 ICU nurses)
ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).
DURATION 12 months at Hammersmith Hospital, ICHT
Detailed description
DaCsi-ICU is a mixed methods research study including the collection of data from patient's medical notes, interviews and quality of life questionnaires following the study schedule of assessments. This study also involves the implementation of an auditory-visual sensory stimulation package in the cardiac ICU at ICHT to participants enrolled in the study.
Digital photos will be shown continuously at the patient's bedside (8am-8pm) after cardiac surgery and will always have reference to time and date. Additionally, videos will be played throughout the patient's stay in the ICU at least three times per day (timepoints: 9am, 2pm,7pm) and upon participant request. Videos will be also played when participants show signs of ICU delirium to reduce its incidence and improve overall health outcomes. Simultaneously, data from patients' medical records will be routinely collected by the research team (e.g., Confusion Assessment Method-ICU, Richmond Agitation Sedation Scale, etc.) to assess whether patients develop delirium during their stay in the ICU.
Interviews with patients and families/friends will be held on three different occasions. The first one will be on the same day as ICU discharge, the second interview will be on the day of hospital discharge and the third one will be carried out up to a month following hospital discharge during their clinical follow-up appointment. Where possible, family members/friends and patient interviews will be conducted together (dyadic interviewing), but the possibility of performing interviews separately will be given so that participants feel able to discuss opinions freely. Nurses' interviews will be held as a one-off and after they have provided direct care to participants who received the proposed intervention.
Each patient will be followed up daily on the wards and once at the monthly follow-up clinic after ICU discharge, where cognitive and emotional assessments will be performed to evaluate delirium outcomes. The research team will also collect relevant information from participants' medical notes if any complications post-ICU discharge arise during inpatient and follow-up stages.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12-patient participants will be submitted to the study intervention.
| Arm | Type | Receives |
|---|---|---|
| Patient Arm | Experimental | Other: Personal Pictures, Other: Family Videos, Other: Family Videos - Intervention as required12 patients will be recruited pre-operatively and submitted to the study intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients
- Female and male patients over the age of 18
- Participants speaking English language and having mental capacity to consent
- Suitable to undergoing cardiac surgery at ICHT.
- Family Members/Friends
Key exclusion criteria (21 listed)
- Patients
- Female and male patients under the age of 18
- Unable to consent to the study pre-operatively
- Significant hearing/visual impairment
- Participants with learning disabilities, pre-existing delirium, dementia or other significant underlying cognitive morbidity
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 |
|---|---|---|
| Personal PicturesDigital photos will be shown continuously at the patient's bedside for 12 hours a day (between 8 am to 8 pm). | Other | Patient Arm |
| Family VideosFamily-recorded videos will be played three times at specific hours of the day - 9 am, 2 pm and 7 pm - throughout patient stay in the ICU | Other | Patient Arm |
| Family Videos - Intervention as requiredThe last video shown will be re-played upon patient request and/or if patients develop ICU delirium. | Other | Patient Arm |
Primary outcome
Feasibility of implementing the study intervention
Time frame: 12 months
The investigators plan to implement a family-focused auditory-visual sensory stimulation intervention to reduce ICU delirium rates post-cardiac surgery. Feasibility will be assessed by exploring facilitator factors and challenges that may arise during the implementation of this intervention. These elements will be recorded on a study reflective log and further discussed within the study team.
3 secondary outcomes
Practicalities of introducing the study intervention
Time frame: 12 months
Acceptability of implementing the study intervention
Time frame: 12 months
Short-term delirium outcomes post-ICU discharge
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 40273276De Azinheira Reguenga MJ, Lampridou S, Pattison N, Brett SJ, Soni S. The use of audio-visual aids to reduce delirium after cardiac surgery in intensive care units (DaCSi-ICU): A feasibility study protocol. PLoS One. 2025 Apr 24;20(4):e0320935. doi: 10.1371/journal.pone.0320935. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Intensive Care Unit Delirium
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Not yet recruitingEarly Phase 1
Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle
Sleep, Delirium
RecruitingPhase 4
Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients
Sleep Disturbance, Delirium
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. This study is not recruiting at the moment.
Maria Reguenga, BSN principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Pictures, Family Videos and Family Videos - Intervention as required in people with Intensive Care Unit Delirium and Cardiac Surgery, run by Imperial College Healthcare NHS 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 9 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Reguenga, BSN (07585095566, maria.reguenga@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing the study intervention (time frame: 12 months). 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 NCT06355570, which also lists 1 linked publication.
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 11 Apr 2024.