Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Malaya
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
Only participant is masked from knowing the assigned group
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old.
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: comparison between two different intubating position (Other)
Outcomes
Primary Outcomes
Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
Time Frame: Intraoperatively , during induction of anaesthesia
Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
Secondary Outcomes
- 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)
Investigators
Dr Shahmini a/p Ganesh
Principal Investigator
University of Malaya