Study of Sleep Quality in the Intensive Care Unit and Association with Weaning from Invasive Ventilation in Patients with Chronic Obstructive Bronchopneumopathy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To identify and measure the association between the presence of abnormal sleep parameters and the outcome of weaning from invasive mechanical ventilation.
研究概览
简要总结
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.
详细描述
- Scientific justification 1.1. Current pathological knowledge
Chronic obstructive pulmonary disease (COPD) is a common disease that will cause more than 3 million deaths worldwide in 2019, making it the third leading cause of death worldwide. Its economic impact is significant, accounting for almost 6% of the total annual healthcare budget in the European Union.
COPD is characterised by persistent respiratory symptoms and airflow limitation due to airway abnormalities, usually caused by significant tobacco and/or environmental exposure.
Patients with COPD may be admitted to intensive care for acute respiratory failure due to COPD (this is a severe exacerbation of BPCO) or for reasons other than COPD.
COPD is a common condition affecting approximately 10% of patients admitted to the ICU. The presence of COPD is an independent risk factor for increased mortality, duration of mechanical ventilation and weaning time from invasive mechanical ventilation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with central nervous system damage or neuromuscular pathology.
- •Pregnant or postpartum patients.
- •Patients or their relatives who object to participating in the study.
结局指标
主要结局
To identify and measure the association between the presence of abnormal sleep parameters and the outcome of weaning from invasive mechanical ventilation.
时间窗: day 7
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.
次要结局
- 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)