DeliriumNCT06344013
The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go!
An observational study of Delirium, run by University Hospital, Brest at 1 site in France.
Trial summary
The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Delirium
- How many people
- 341 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 31 Jul 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: French ICU doctors
Who may be able to join
- French ICU doctors
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention, and Management, E: Early Mobility and Exercise, F: Family Engagement and Empowerment) bundle. French ICU doctors will be asked to answer a questionnaire available online.
- Conditions
- Delirium
- Keywords
- ABCDEF bundle, ICU delirium, sedation, exercise, family
- Medical subject headings
- Delirium, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge and compliance of French intensive care units with the ABCDEF
Measured: one-time evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jul 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344013
- Sponsor's protocol ID
- 29BRC24.0034 - BUNDLE ABCDEF
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go!
- ClinicalTrials.gov ID
- NCT06344013
- Acronym / sponsor ID
- 29BRC24.0034 - BUNDLE ABCDEF
- Conditions
- Delirium
- Keywords
- ABCDEF bundle, ICU delirium, sedation, exercise, family
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 3 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.
The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention, and Management, E: Early Mobility and Exercise, F: Family Engagement and Empowerment) bundle. French ICU doctors will be asked to answer a questionnaire available online.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- French ICU doctors
Key inclusion criteria (1 listed)
- French ICU doctors
Key exclusion criteria (0 listed)
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
knowledge and compliance of French intensive care units with the ABCDEF
Time frame: one-time evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Delirium, run by University Hospital, Brest 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 3 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge and compliance of French intensive care units with the ABCDEF (time frame: one-time evaluation). 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 3 Apr 2024.