NCT06653933Not yet recruiting
Study of Sleep Quality in the Intensive Care Unit and Association with Weaning from Invasive Ventilation in Patients with Chronic Obstructive Bronchopneumopathy.
Source: ClinicalTrials.gov · Last updated 23 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 42 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- University Hospital, Grenoble
- Diseases
- COPD
- NCT number
- NCT06653933
What you commit to
- Study type: Observational
- Planned participants: 42
- From 1 Jan 2025 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients with central nervous system damage or neuromuscular pathology.
- Pregnant or postpartum patients.
- Patients or their relatives who object to participating in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grenoble Alpes University Hospital Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.