The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- desaturations during extubation
研究概览
简要总结
Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations
详细描述
Study realise on university hospital on Lille in France. Patients inclusion is prospective and randomised in three groups. First group : extubation is realised with aspiration in tracheal tube during removal tube Second group : extubation is realised without aspiration but with APL valve set to 20cmH20 Third group : extubation is realised without aspiration but with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room
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 (Participant)
盲法说明
patients under anaesthesia at randomization
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visceral or urological surgery
- •Scheduled surgery
- •Surgical or patient requirement: placement of an arterial catheter
- •Supine position
- •Post-surgical extubation scheduled in the operating room
- •Minimum age of 18 years
- •Informed and signed consent
排除标准
- •Severe obesity (BMI over 35kg/m2)
- •pregnant woman
- •Acute or chronic preoperative respiratory pathology.
- •Sleep apnea syndrome
- •Inability to receive informed information (does not speak, read or understand French)
- •Patient under guardianship or curatorship
- •Lack of social security coverage
- •History of intubation or criteria for difficult intubation or ventilation.
研究组 & 干预措施
control group
Classical extubation technique : ETT was removed with continuous endotracheal suction
VSPEP
ETT was removed with APL valve set to 20cmH2O
干预措施: positive pressure during extubation procedure (Procedure)
VSAIPEP
ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room
干预措施: positive pressure during extubation procedure (Procedure)
结局指标
主要结局
desaturations during extubation
时间窗: 1 minute after extubation
saturation \<92%
次要结局
- desaturation postoperatory(5 and 30 minutes after extubation)
- atelectasis(30 minutes after extubation)
- feasibility and acceptance of both techniques pressure positive extubation(15 minutes after extubation)
- use of oxygen(day 7)
- hypoxemia post operatory(1 and 30 minutes after extubation)
- awakening time(through extubation completion, an average 2 minutes)
- post operative complications(day 7 and day 28)