2024-517670-15-00招募中3 期
Randomized Clinical Trial of Inhaled Sedation with Sevoflurane in Critically Ill Patients at Risk of Developing the Acute Respiratory Distress Syndrome
CHU Gabriel-Montpied1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月10日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- longitudinal evolution in the PaO2/FiO2 ratio
研究概览
简要总结
To assess the efficacy of inhaled sevoflurane, compared to current intravenous sedation practice, for improving PaO2/FiO2 in ICU patients at high risk for ARDS.
详细描述
MAIN OBJECTIVE To assess the efficacy of inhaled sevoflurane, compared to current intravenous sedation practice, for improving PaO2/FiO2 in ICU patients at high risk for ARDS.
HYPOTHESIS The investigators hypothesized that a strategy of inhaled sedation with sevoflurane could be more effective than current intravenous sedation practice at improving pulmonary function during the early days of ICU admission, in patients at risk of ARDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Sedation
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS equals to, or greater than 4
- •Patient under invasive mechanical ventilation
- •With expected duration of sedation superior or equal to 4 hours
- •Affiliation to the French Sécurité Sociale
排除标准
- •Patient under a tutelage measure
- •Presence of ARDS prior to randomization
- •Endotracheal ventilation for greater than 24 hours prior to randomization
- •Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
- •Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (i.e. height inferior to 134cm for a man and 139cm for a woman)
- •Moribund patient, i.e. not expected to survive 24 hours despite intensive care
- •Previous hypersensitivity or anaphylactic reaction to sevoflurane or to the intravenous sedation agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine)
- •Contra-indications to the intravenous sedative agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine
- •Medical history of malignant hyperthermia
- •Long QT syndrome at risk of arrhythmic events
- •Medical history of liver disease attributed to previous exposure to a halogenated agent (including sevoflurane)
- •Suspected or proven intracranial hypertension
- •Enrollment in another interventional trial with direct impact on oxygenation
- •Patient under judicial protection, guardianship or supervision
- •Patient under psychiatric care as defined by art. L1121-6 of the Public Health Code
- •Known pregnancy
结局指标
主要结局
longitudinal evolution in the PaO2/FiO2 ratio
longitudinal evolution in the PaO2/FiO2 ratio
次要结局
- Progression to ARDS will be assessed according to the Berlin criteria, including chest radiographs
- Rate of pneumonia
- Ventilator-free days
- Organ failure-free days
- Mortality
- Length of ICU-stay
- Physiological measures
- ICU-acquired delirium
- Biomarker measurements
研究者
Lise Laclautre
Scientific
CHU Gabriel-Montpied
研究点 (1)
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