Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
研究概览
简要总结
This study is aimed to conduct a randomised controlled trial comparing endotracheal intubation (ETI) in bed up head elevation BUHE position versus sniffing position in simulated rapid sequence induction (RSI).
Objective is to determine if the time taken for intubation in the bed up head elevated position is non-inferior to time taken for intubation in the sniffing position.
The hypotheses:
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position is non inferior to time required for DL and successful ETI in the sniffing position.
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position improve POGO score.
- In patients undergoing rapid sequence induction in simulated emergency surgery under general anaesthesia, direct laryngoscopy (DL) and ETI in the BUHE position reduces airway related complications.
Terminology:
Direct laryngoscopy (DL) and Endotracheal intubation (ETI): Is a method of inserting a breathing tube into the trachea (windpipe) once patient undergo general anaesthesia.
Bed up head elevation (BUHE): Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.
Sniffing position: Maintaining supine position with head elevation with head rest.
Rapid sequence induction (RSI): An established method of inducing anaesthesia in patients who are at risk of aspiration of gastric contents into the lungs. It involves loss of consciousness during cricoid pressure followed by intubation without face mask ventilation. The aim is to intubate the trachea as quickly and as safely as possible.
POGO score: Percentage of glottic opening
Cricoid Pressure (CP): Maneuvre to prevent regurgitation of gastric contents during induction of anaesthesia by temporary occlusion of the upper end of the esophagus by backward pressure of cricoid cartilage against bodies of cervical vertebrae.
详细描述
All patients from age 18 years old to 75 years old undergoing elective surgery under general anaesthesia in operating theater of University Malaya Medical Centre over a period of 15 months, from April 2018 to June 2019 will be included and recruited based on inclusion and exclusion criteria.
Those patient that fulfilled the criteria and consented for the study will be randomized to 2 group.
i) BUHE group: Bed up at 20-30 degree aiming alignment between the external auditory meatus with sternal notch.
ii) Sniffing group: Maintaining supine position with head elevation with head rest (foam donut).
Induction of anaesthesia starts with:
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
- Single (Participant)
盲法说明
Only participant is masked from knowing the assigned group
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
- 是
入选标准
- •All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old.
排除标准
- •Patients with airway obstruction
- •Patients with contraindication to neck extension
- •BMI> 35kg/m2
- •Patient with history of difficult airway from previous intubation history
- •Only single intubation will be included if patients had multiple surgery during their hospital stay
- •Patients with ischaemic heart disease, cerebrovascular diseases and respiratory disease
研究组 & 干预措施
Sniffing position
Subject will be maintained in standard intubation position which is supine position with head elevation with head rest (foam donut).
Bed up head elevation position
Subject will be maintained at bed up 20-30 degree aiming alignment between the external auditory meatus with sternal notch
干预措施: comparison between two different intubating position (Other)
结局指标
主要结局
Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
时间窗: Intraoperatively , during induction of anaesthesia
Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
次要结局
- Laryngeal exposure measured via POGO score(Intraoperatively , during induction of anaesthesia)
- Occurrence of esophageal intubation(Intraoperatively , during induction of anaesthesia)
- Number of laryngoscopy and intubation attempt(Intraoperatively , during induction of anaesthesia)
- Occurrence of difficult intubation(Intraoperatively , during induction of anaesthesia)
- Occurrence of hypoxia(Intraoperatively , during induction of anaesthesia)
- The use of any other airway adjunct or external laryngeal manipulation to assist in intubation(Intraoperatively , during induction of anaesthesia)
- Occurrence of airway trauma(Intraoperatively , during induction of anaesthesia)
研究者
Dr Shahmini a/p Ganesh
Principal Investigator
University of Malaya