Removal of the Intubation Tube Under Positive Pressure With or Without Endotracheal Suctioning During Extubation in Intensive Care: a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Respiratoy/oxygenation index (ROX index)
研究概览
简要总结
The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
详细描述
This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).
Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Adult patient
- •Intubated for more than 48 hours
- •Patient for whom extubation is prescribed by the patient's physician
排除标准
- •Headboard restriction>30°.
- •Decision to limit active treatment in advance of reintubation
- •Protected person (under guardianship or curatorship)
- •Person under court protection
- •Persons deprived of liberty
- •Persons not affiliated to a social security scheme
- •Pregnant or breast-feeding woman
- •No co-inclusion with a study whose period of interest is follow-up within 3 hours of extubation.
研究组 & 干预措施
Suctionning Extubation (experimental arm)
Endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.
干预措施: Suctionning extubation (Procedure)
No Suctionning Extubation (control arm)
No endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.
干预措施: No suctionning Extubation (Procedure)
结局指标
主要结局
Respiratoy/oxygenation index (ROX index)
时间窗: 3 hours after extubation
Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment)
次要结局
- Airway clearance technique(During 24 hours after extubation)
- Mechanical ventilation weaning failure(During 7 days after extubation)
- ROX index evolution(During 3 hours after extubation)
- Pneumonia after extubation(During 7 days after extubation)