Sleep QualityWEAN SLEEP 2NCT02911506
Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure
An observational study of Sleep Quality and Extubation Failure, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Quality, Extubation Failure
- What is being tested?
- Polysomnography
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care unit patients, intubated at least 24 hours, at risk of extubation failure
Who may be able to join
- Intensive care units patients intubated for at least 24 hours with at least on of the four following risk factor : aged of 65 years or more, any underlying chronic cardiac or lung disease, mechanical ventilation for more than 7 days.
- aged of 18 years or more
Who cannot join
- peripheral or central nervous system pathology
- known psychiatric pathology or agitation
- patient with decision of no reintubation
- patient refusal
- clinical worsening before polysomnography ( shock with vasopressors drugs, coma, PaO2/FiO2 ratio < 150 with respiratory distress signs, coma with Glasgow scale <8)
- pregnant or breastfeeding women
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- patient under legal guardianship or protection
- patient with no health insurance coverage
- aged < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.
- Conditions
- Sleep Quality, Extubation Failure
- Being tested
- Polysomnography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sleep quality by polysomnography recording on the extubation day.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911506
- Sponsor's protocol ID
- WEAN SLEEP 2
- Acronym
- WEAN SLEEP 2
- Status last verified
- May 2020
- First submitted
- 14 Sep 2016
- Last updated
- 1 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure
- ClinicalTrials.gov ID
- NCT02911506
- Acronym / sponsor ID
- WEAN SLEEP 2 / WEAN SLEEP 2
- Conditions
- Sleep Quality, Extubation Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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 aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients, intubated at least 24 hours, at risk of extubation failure
Key inclusion criteria (2 listed)
- Intensive care units patients intubated for at least 24 hours with at least on of the four following risk factor : aged of 65 years or more, any underlying chronic cardiac or lung disease, mechanical ventilation for more than 7 days.
- aged of 18 years or more
Key exclusion criteria (9 listed)
- peripheral or central nervous system pathology
- known psychiatric pathology or agitation
- patient with decision of no reintubation
- patient refusal
- clinical worsening before polysomnography ( shock with vasopressors drugs, coma, PaO2/FiO2 ratio < 150 with respiratory distress signs, coma with Glasgow scale <8)
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 |
|---|---|---|
| Polysomnography | Other | – |
Primary outcome
Evaluation of sleep quality by polysomnography recording on the extubation day.
Time frame: 24 hours
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 1 Jun 2020.
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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 Sleep Quality and Extubation Failure, run by Poitiers University Hospital 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 9 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 1 Jun 2020. 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?
Evaluation of sleep quality by polysomnography recording on the extubation day. (time frame: 24 hours). 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 1 Jun 2020.