SedationALGOSEDANCT03186521
Impact of a Nurse Implemented Sedation and Analgesia Algorithm in Surgical Intensive Care Unit
An observational study of Sedation, run by University Hospital, Caen at 1 site in France.
Trial summary
To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedation
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Dec 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mechanically ventilated patients under sedation predicted to last 48hrs or more and aged over 18 years can be included.
Who may be able to join
- Any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours.
- Age greater than 18 years.
Who cannot join
- Patient under guardianship or <18.
- Comatose, intracranial hypertension, brain damage, Acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), Post Cardiac Arrest care, Pregnancy
- Neuromuscular blocking agents at the time of inclusion
- Secondary Exclusion criteria:
- Extubation <48 hours after inclusion
- Deaths <48 hours after inclusion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
POTTIER
Caen, 14033
Véronique POTTIER, MD, +33231064736, pottier-v@chu-caen.fr
About this study
Official title: Impact of a Nurse Implemented Sedation and Analgesia Algorithm on Complications of Critical Illness and Outcome of Surgical Intensive Care Patients
To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.
Read the detailed description
Outcome Measures : The primary objective of this non-invasive, non-interventional study is to show that the establishment of a titration algorithm for sedation and analgesia administered by nurses is more beneficial to the patient than the use of such a drug without a suitable regimen. The goal is to improve the quality of our painkillers and sedative drugs use needed in the intensive care environment in order to decrease the morbidity and mortality associated with it, without altering patient comfort and tolerance to the environment. For this we propose to collect a database including patient demographic details, pharmacological information and any possible complications during the ICU stay as well as a distant assessment exploring the psychological complications (3, 6 months and 1 year). The primary endpoint will be the duration of mechanical ventilation, and secondary endpoints, the length of stay in ICU and in hospital, mortality and other complications.
Methods: The two study populations will be in two distinct time periods, the first so-called control without any modification of practices, and the second, by introducing the algorithm with the same drugs being used. Quantitative comparisons of data following a normal distribution will be done using a Student's t test. Otherwise quantitative data will be compared using a Mann-Whitney test or Wilcoxon. The comparison of qualitative data will be done using a Fisher exact test. To increase the power of this before / after study, we calculated the number of patients to be included by period, based on the reduction in duration of mechanical ventilation with such protocols in the literature, and the mean duration of mechanical ventilation in our unit before the study.
- Conditions
- Sedation
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation
Duration between endotracheale intubation and extubation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique POTTIER, MD, Principal investigator, department of anesthesia and intensive care, caen university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186521
- Sponsor's protocol ID
- 15-147
- Acronym
- ALGOSEDA
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nurse Implemented Sedation and Analgesia Algorithm on Complications of Critical Illness and Outcome of Surgical Intensive Care Patients
- ClinicalTrials.gov ID
- NCT03186521
- Acronym / sponsor ID
- ALGOSEDA / 15-147
- Conditions
- Sedation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jun 2017 (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.
To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.
Detailed description
Outcome Measures : The primary objective of this non-invasive, non-interventional study is to show that the establishment of a titration algorithm for sedation and analgesia administered by nurses is more beneficial to the patient than the use of such a drug without a suitable regimen. The goal is to improve the quality of our painkillers and sedative drugs use needed in the intensive care environment in order to decrease the morbidity and mortality associated with it, without altering patient comfort and tolerance to the environment. For this we propose to collect a database including patient demographic details, pharmacological information and any possible complications during the ICU stay as well as a distant assessment exploring the psychological complications (3, 6 months and 1 year). The primary endpoint will be the duration of mechanical ventilation, and secondary endpoints, the length of stay in ICU and in hospital, mortality and other complications.
Methods: The two study populations will be in two distinct time periods, the first so-called control without any modification of practices, and the second, by introducing the algorithm with the same drugs being used. Quantitative comparisons of data following a normal distribution will be done using a Student's t test. Otherwise quantitative data will be compared using a Mann-Whitney test or Wilcoxon. The comparison of qualitative data will be done using a Fisher exact test. To increase the power of this before / after study, we calculated the number of patients to be included by period, based on the reduction in duration of mechanical ventilation with such protocols in the literature, and the mean duration of mechanical ventilation in our unit before the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients under sedation predicted to last 48hrs or more and aged over 18 years can be included.
Key inclusion criteria (2 listed)
- Any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours.
- Age greater than 18 years.
Key exclusion criteria (6 listed)
- Patient under guardianship or <18.
- Comatose, intracranial hypertension, brain damage, Acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), Post Cardiac Arrest care, Pregnancy
- Neuromuscular blocking agents at the time of inclusion
- Extubation <48 hours after inclusion
- Deaths <48 hours after inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of mechanical ventilation
Time frame: baseline
Duration between endotracheale intubation and extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Véronique POTTIER, MD principal investigator
department of anesthesia and intensive care, caen university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation, run by University Hospital, Caen at 1 site in France.
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 2 inclusion and 6 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 14 Jun 2017. 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 France. 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 Véronique POTTIER, MD (33231064736, pottier-v@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of mechanical ventilation (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2017.