About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with central nervous system damage or neuromuscular pathology.
Pregnant or postpartum patients.
Patients or their relatives who object to participating in the study.
Trial population
All patients with COPD who received invasive mechanical ventilation for more than 24 hours in the intensive care unit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
To identify for and measure the association between the presence of sleep disorders and extubation failure.
Failure or success of extubation.
To search for and measure the association between the presence of sleep parameters and the duration of invasive mechanical ventilation after weaning from sedation.
Duration of invasive mechanical ventilation in hours after weaning from sedation and patient awakening (Glasgow score ≥ 8).
To search for and measure the association between the presence of sleep parameters and self-extubation.
Rate of self-extubation.
To detect and measure the association between the presence of sleep parameters and the impact of the occurrence of ventilator-acquired pneumonia after enrolment.
Incidence of ventilator-acquired pneumonia (VAP) after enrolment.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: