Intubation of Obese Patients in the Operating Room With or Without Face Mask Ventilation. A Randomized Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 725
- 试验地点
- 13
- 主要终点
- To compare the effectiveness of an intubation sequence "with ventilation during apnea" versus a sequence "without ventilation during apnea" in preventing complications related to intubation of the obese patient in the operating room
研究概览
简要总结
The aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these patients.
详细描述
Anesthesia consultation or pre-anesthesia visit:
- screening for inclusion and non-inclusion criteria
- patient information
- collection of consent
- inclusion
D0 (day of inclusion):
- before general anesthesia : collection of epidemiological data (history + clinical examinations) + randomization (Arm A/Not Vent : intubation without ventilation or Arm B/Vent : intubation with ventilation)
- general anesthesia : intubation according to randomization arm + collection primary endpoint + conduct of the intubation procedure + morbidity of the intubation procedure
- after general anesthesia : collection of secondary endpoints + conduct of the intubation procedure + morbidity of the intubation procedure + intraoperative respiratory morbidity
- post-interventional care room : collection of clinical parameters in the ICU : postoperative morbidity + study discharge (hospital discharge)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •patient requiring general anesthesia with intubation for surgery or scheduled endoscopic procedures
- •age > 18 years
- •with a BMI superior or equal to 35kg.m-²
- •patient having signed an informed consent
- •Non-inclusion criteria:
- •ambient air saturation <90%
- •urgent surgery < 24 hours
- •cardio-thoracic surgery
- •mask ventilation not possible (e.g. ATCD, cervical irradiation, fixed mandible)
- •formal contraindication to mask ventilation (e.g. occlusive syndrome, non fasting patient, symptomatic gastroesophageal reflux untreated or persistent under treatment)
- •wish of the operator for high flow oxygen preoxygenation
- •wish of an intubation without curare by the operator
- •pregnant or breast-feeding women
- •protected adults (guardianship, curatorship or safeguard of justice)
- •participation in another randomized clinical research study concerning preoxygenation and relevant to the primary endpoint
- •absence of affiliation to the French social security system
排除标准
- 未提供
研究组 & 干预措施
Without ventilation
No ventilation sequence during the intubation period and without face mask ventilation during the apnea period
干预措施: No ventilation with face mask (Procedure)
With ventilation
Sequence "with ventilation" during the apnea period with face mask ventilation
干预措施: Ventilation with face mask (Procedure)
结局指标
主要结局
To compare the effectiveness of an intubation sequence "with ventilation during apnea" versus a sequence "without ventilation during apnea" in preventing complications related to intubation of the obese patient in the operating room
时间窗: From induction of general anesthesia to 10 minutes after intubation
Comparison of the incidence of intubation-related complications. Complications identified for the primary endpoint will be: desaturations \< 95%, need for 2 or more intubation attempts (including alternative technique), occurrence of inhalation/regurgitation or hypotension with systolic blood pressure \< 80 mmHg, with or without amine. Complications will be recorded from induction of general anesthesia to 10 minutes after intubation
次要结局
- Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask(During the general anesthesia, up to 8 hours)
- Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask(up to 8 hours)
- Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask(up to 28 days)
- Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask(During the general anesthesia, up to 10 minutes)
- Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask(5 minutes, 30 minutes and 1 hour after intubation)