NCT04381949已完成不适用
Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery: Prospective Randomized Study
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2022年8月3日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Desaturation rate
研究概览
简要总结
Evaluation of a postoperative tracheal extubation protocol under positive pressure in accordance with international recommendations.
Two arms: the first with "classic" extubation with disconnection of the respirator and the second with extubation without disconnection of the respiratory, as recommended.
Computer Randomization with a 1: 1 ration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age> 18 and <80
- •Patient going to benefit from general anesthesia with orotracheal intubation for surgery lasting more than 60 minutes at the visceral surgery unit of the Rouen University Hospital.
- •Person affiliated to a social security scheme
- •Person who has read and understood the newsletter and signed the consent form
排除标准
- •Minor patients or age> 80 years
- •History of Obstructive Sleep Apnea Syndrome
- •Chronic respiratory failure / History of chronic obstructive pulmonary disease
- •Surgery < 60 minutes
- •Use of methylene blue intraoperatively
- •Extubation finally performed in the operating room
- •orotracheal intubation difficult to induce general anesthesia
- •Suspected inhalation during orotracheal intubation
- •Pneumothorax per operative
- •Heart failure authenticated by trans thoracic ultrasound <50%
- •Neuromuscular pathologies (myasthenia gravis, myopathies)
- •Body mass index> 35
- •Emergency surgery
- •Patient with an ASA IV score (ie according to the definition of the American Society of Anesthesiology)
- •Major surgical complications (hemorrhagic shock)
- •Major anesthetic complications (anaphylactic shock, bronchospasm)
- •Pregnant or parturient or lactating woman or woman of childbearing age without proven contraception
- •Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
研究组 & 干预措施
Standard extubation Arm
No Intervention
Positive pressure extubation arm
Experimental
干预措施: positive pressure extubation (Procedure)
结局指标
主要结局
Desaturation rate
时间窗: within one hour of tracheal extubation
defined by a SpO2 \< 92%
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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