Study of Sleep Quality in the Intensive Care Unit and Association with Weaning from Invasive Ventilation in Patients with Chronic Obstructive Bronchopneumopathy.
SLEECOP
1 other identifier
observational
42
1 country
1
Brief Summary
Patients admitted in ICU may require invasive mechanical ventilation, using a mechanical ventilator and an endotracheal tube. In ICU, a prolonged duration of invasive mechanical ventilation may be responsible for ventilator-induced lung injury, pulmonary infection, prolonged administration of sedation, neuromyopathy and prolonged length of stay. The goal of the ICU healthcare teams is therefore to reduce the duration of invasive mechanical ventilation as much as possible. ICU patients have many sleep disturbances: sleep fragmentation, sleep stage changes, changes in sleep architecture. These sleep disturbances are due to sedation and analgesia, delirium, patient care activities, noise and altered day-night cycles. Chronic obstructive pulmonary disease (COPD) is a common respiratory disease. COPD complicates the management of invasive mechanical ventilation, particularly weaning of this invasive mechanical ventilation and extubation (removal of the intubation tube). To reduce the risk of reintubation, it is recommended that a weaning test is performed prior to extubation. The purpose of this test is to simulate the conditions of breathing without the help of a ventilator after extubation. If the weaning test is successful, the patient can theoretically be extubated. There are several causes associated with extubation failure, but studies suggest that sleep deprivation or poor sleep quality in the nights before extubation is one of them. In addition, patients with COPD often have chronic sleep disturbances or induced by their stay in the ICU (asthenia, bed rest, anxiety, sedation, etc.). The aim of our study will be to compare the sleep characteristics of COPD patients with a failed weaning test and those with a successful test. Our hypothesis is that patients with a failed weaning test will have more sleep disturbances in the period of 72 hours before the weaning test.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Jan 2025
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2024
CompletedFirst Posted
Study publicly available on registry
October 23, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
October 23, 2024
October 1, 2024
2.1 years
October 21, 2024
October 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To identify and measure the association between the presence of abnormal sleep parameters and the outcome of weaning from invasive mechanical ventilation.
Sleep parameters will be analysed according to a hierarchical sequential analysis with the following order 1. No REM sleep, 2. Atypical sleep and 3. Sleep time. Results (failure or success) of the invasive mechanical ventilation test performed according to the recommendations of the International Conference on Warning Consensus.
day 7
Secondary Outcomes (4)
To identify for and measure the association between the presence of sleep disorders and extubation failure.
day 7
To search for and measure the association between the presence of sleep parameters and the duration of invasive mechanical ventilation after weaning from sedation.
day 7
To search for and measure the association between the presence of sleep parameters and self-extubation.
day 7
To detect and measure the association between the presence of sleep parameters and the impact of the occurrence of ventilator-acquired pneumonia after enrolment.
day 7
Study Arms (1)
COPD patients with invasive mechanical ventilation in ICU
All patients with COPD who received invasive mechanical ventilation for more than 24 hours in the intensive care unit.
Eligibility Criteria
All patients with COPD who received invasive mechanical ventilation for more than 24 hours in the intensive care unit.
You may qualify if:
- Patients diagnosed with COPD according to the GOLD criteria.
- Mechanical ventilation by endotracheal tube and mechanical ventilation for \> 24 hours.
- Withdrawal of treatment with continuous sedation and/or neuroleptics.
- Adequate recovery with Glasgow Coma Scale ≥ 8.
You may not qualify if:
- Patients with central nervous system damage or neuromuscular pathology.
- Pregnant or postpartum patients.
- Patients or their relatives who object to participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Grenoble Alpes University Hospital
Grenoble, 38043, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis-Marie GALERNEAU, MD, PhD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2024
First Posted
October 23, 2024
Study Start
January 1, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share