NCT03783468撤回不适用
Early LIght Sedation Pressure Support in ARDS Patients
University Hospital, Lille0 个研究点开始时间: 2021年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- transpulmonary pressure at early stabilization of patient
研究概览
简要总结
Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.
Light sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure.
The goal of the study is to measure transpulmonary pressure before sedation decrease and after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •ARDS (Berlin definition)
- •social insurance
排除标准
- •neuromuscular disorders
- •pregnancy
- •need for muscular paralysis
- •need for deep neurosedation
- •more than 24hrs of artificial ventilation
- •cystic fibrosis
结局指标
主要结局
transpulmonary pressure at early stabilization of patient
时间窗: when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours
transpulmonary pressure (Paw - Peso \< 24 cmH2O)
次要结局
- oxygenation modification(stabilization of ventilator settings; 1hour after stabilization of ventilator settings)
- ventilator free days(during the first 28 days)
- arterial pressure modification(stabilization of ventilator settings; 1hour after stabilization of ventilator settings)
- muscular volume decrease(at 24 hours; at day of extubation; ICU discharge, an average 16 days)
- delirium in ICU(ICU discharge, an average 16 days)
- Heart rate modification(stabilization of ventilator settings;1hour after stabilization of ventilator settings)
- acquired neuromyopathy(ICU discharge, an average 16 days)
- vasopressor dose modification(stabilization of ventilator settings ; 1hour after stabilization of ventilator settings)
- change of the functional respiratory parameters from baseline at 6 months(at 6 months)
- number of auto extubation(whatever until ICU discharge, an average 16 days)
- PTSD(at 6 months)
研究者
相似试验
Unknown
4 期
Impact of Various Sedation Regimens on the Incidence of DeliriumDeliriumNCT02117726Shandong Provincial Hospital320
已完成
不适用
Assessment of Sedation Depth Using Processed EEG in ICU Patients With ARDS Receiving Neuromuscular Blockade: A Prospective Observational Study"Sedation ComplicationAcute Respiratory Distress Syndrome Due to COVID-19Anesthesia AwarenessNCT06337877Tepecik Training and Research Hospital52
已完成
不适用
Effects of Sedation on Transpulmonary Pressure and Lung HomogenousARDSNCT03237806Southeast University, China24
招募中
4 期
Sedative Effect and Safety of Remimazolam Besylate in ARDS PatientsRespiratory Distress SyndromeNCT05758597Zhiming Jiang100
已完成
3 期
Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill PatientsCritical Illness and Mechanical VentilationNCT01728558Australian and New Zealand Intensive Care Research Centre4,000