Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Oxygen withdrawal time
研究概览
简要总结
The purpose of this study by automated control of oxygen supply in the immediate postoperative period is to show the possibility of immediate weaning in the postoperative period in case of remifentanil use and complete reversion of curarization.
详细描述
The main hypothesis of this study is that classical oxygen therapy at 3l/min is futile in the postoperative period of a so-called modern anaesthesia and that a total weaning within one hour after arrival in the ICU is possible whatever the postoperative position of the patient. The aim is therefore to include patients who have to undergo a scheduled surgery under anaesthetic sedation (analgesia with remifentanil) or general anaesthesia (combining remifentanil, propofol rocuronium) for ambulatory surgery. The trial is interventional, randomized, monocentric to demonstrate the absence of interest of prolonged postoperative oxygen therapy under specific intraoperative conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients managed by the Anesthesia Department of the Foch Hospital;
- •Anesthetic sedation (analgesia with remifentanil) or general anesthesia (combining remifentanil, propofol and possibly rocuronium);
- •Men or women over 18 and under 80 years of age;
- •To benefit from a surgical intervention scheduled > 48 hours in relation to the procedure;
- •Scheduled outpatient surgery;
- •Have signed a consent form;
- •Be affiliated to a health insurance plan.
排除标准
- •Pregnant or nursing patients;
- •Oxygen dependent preoperatively or at risk of oxygen dependence postoperatively;
- •Lung resection surgery;
- •Brain surgery (intracerebral neurosurgery); ENT surgery requiring a half-seated position after the operation;
- •Being deprived of liberty or under guardianship.
结局指标
主要结局
Oxygen withdrawal time
时间窗: 1 day
Time (min) to achieve zero O2 flow for at least 15 consecutive minutes
次要结局
- Rate of patients weaned within the first hour(1 day)
- Signature time in the ICU(1 day)
- Complications after stay in hospital(30 days)
- The patient's comfort(1 day)
- Mortality during stay in hospital(30 days)
- Complications during stay in intensive care unit(30 days)
- Complications during hospital stay(30 days)
- Amount of O2 needed to reach the target saturation value (SpO2)(1 day)
- Maximum flow rate during the evaluation period(1 day)