Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,472
- 试验地点
- 1
- 主要终点
- Incidence of lung aspiration
研究概览
简要总结
Lung aspiration can occur when a rapid sequence induction of anesthesia is performed (emergency and/or presence of at least one risk factor for regurgitation of stomach contents).
The aim of this study is to assess the Sellick maneuver, which is recommended for patient at high risk of aspiration of gastric content during induction of general anesthesia, despite the lack of solid evidence of its efficacy and possible adverse effects The primary outcome of this non inferiority study is the incidence of lung aspiration whether this maneuver is effectively applied or sham.
详细描述
Introduction:
Lung aspiration is an inherent complication of the loss of protective upper airway reflexes during general anesthesia. Its incidence is low in elective surgery, when preoperative fasting rules have been complied and in absence of risk factors for regurgitation of gastric contents. In emergency conditions, non-compliance with preoperative fasting rules and delayed gastric emptying increase the risk of regurgitation and therefore lung aspiration of gastric contents. In this context, a rapid sequence induction of anaesthesia is recommended to minimize the risk of regurgitation which combines the use of short delay and short duration of action anesthetics agents associated with the application of a Sellick maneuver. The goal of this maneuver is to collapse the esophagus by compressing it between the cricoid cartilage and the fifth cervical vertebra. Because of the low level of evidence supporting the Sellick maneuver in the literature, this maneuver, remains controversial although recommended.
Hypothesis: The aim of this study is to assess the Sellick maneuver during rapid sequence induction in adults (pregnant women excluded) by comparing the incidence of lung aspiration whether this maneuver is applied or sham, in a noninferiority trial.
Primary endpoint: Incidence of lung aspiration
Secondary endpoints: Cormack and Lehane Grade , frequency of difficult intubation, frequency of impossible intubation, effect of releasing the Sellick maneuver on these three criteria, frequency of aspiration pneumonia within 24 hours, frequency of complications due to the Sellick maneuver (esophageal rupture and cricoid cartilage fracture rates) and mortality at day 28 or at 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
- Prevention
- 盲法
- Double (Participant, 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
- •Patients older than 18 yr undergoing general anaesthesia requiring rapid sequence induction (full stomach or presence of at least one risk factor for regurgitation of stomach content) are eligible.
- •Obtain informed consent from the patient or a close relative/surrogate. Should such a person be absent, the patient will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow.
排除标准
- •Non consent patients,
- •Pregnancy,
- •Contraindication to Sellick maneuver
- •Contraindication to succinylcholine
- •Patients with predictive signs of bronchopneumonia during the preanesthetic consultation ,
- •Patients with pulmonary contusion
- •Upper respiratory tract abnormalities
- •Laryngeal trauma
- •Patients requiring an alternative to direct laryngoscopy
- •Patients with troubles of consciousness
- •Use of plastic single used laryngoscopic blade
- •Use of rocuronium as neuromuscular blockade agent
研究组 & 干预措施
sham arm
sham sellick maneuver
干预措施: sham sellick maneuver (Other)
sellick arm
effective sellick maneuver
干预措施: effective sellick maneuver (Other)
结局指标
主要结局
Incidence of lung aspiration
时间窗: Within 1 hour
in the operating room presence of gastric fluid on the vocal cords at the orotracheal intubation or in endotracheal suction when performed immediately after intubation
次要结局
- Cormack and Lehane Grade(Within 1 hour)
- Number of times the Sellick maneuver should be discontinued(Within 1 hour)
- Incidence of difficult and impossible intubation(Within 1 hour)
- Incidence of aspiration pneumonia(within the 24 hours)
- Incidence of oesophageal rupture(day 28)
- Incidence of cricoid cartilage fracture(day 28)
- Effects of releasing the Sellick maneuver on the conditions of tracheal intubation assessed by Cormack and Lehane grade(Within 1 hour)
- Frequency of use of a mask ventilation(Within 1 hour)
- Mortality(Hospital discharge Hospital discharge if anterior at day 28)
- Mortality(day 28)