Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction.

Study Overview
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Brief Summary
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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
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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: preoxygenation with 100% oxygen for 3-5 min performed until end tidal oxygen of 85% achieved. A pre-calculated dose of induction agent is administered, followed immediately by a neuromuscular blocking agent. (IV Fentanyl 2mcg/kg,IV Propofol 2-3mg/kg,IV Rocuronium 1mg/kg). Cricoid pressure at 10 Newton is applied increasing to 30 Newton once consciousness is lost. After adequate neuromuscular blockade,both group patients will be intubated by one investigator via direct laryngoscopy using Macintosh blade size 3 or 4. Time taken from insertion of Macintosh blade into oral cavity till confirmation of endotracheal tube placement via detection of CO2 on the end tidal CO2 monitor will be recorded.

Official Title
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Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial

Conditions
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Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction

Intervention / Treatment
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* Other: comparison between two different intubating position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients undergoing elective surgery under general anaesthesia from age 18 years old to 75 years old selected. Written informed consent will be obtained prior to enrolment. Randomisation into 2 groups (BUHE and sniffing position) will be done via computer generated sequences. Subsequently, will be placed into sealed envelopes. The next available envelope will be selected and open for that particular patient at the time of enrolment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sniffing position<br>Subject will be maintained in standard intubation position which is supine position with head elevation with head rest (foam donut). | |
| Experimental: Bed up head elevation position<br>Subject will be maintained at bed up 20-30 degree aiming alignment between the external auditory meatus with sternal notch | Other: comparison between two different intubating position<br>* Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave | Measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave | Intraoperatively , during induction of anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of laryngoscopy and intubation attempt | Number of attempts taken by investigator to obtain successful endotracheal intubation in both arms | Intraoperatively , during induction of anaesthesia | 
| Laryngeal exposure measured via POGO score | Percentage of glottic opening during laryngoscopy | Intraoperatively , during induction of anaesthesia | 
| Occurrence of difficult intubation | Defined as ≥3 attempts at intubation | Intraoperatively , during induction of anaesthesia | 
| Occurrence of hypoxia | Hypoxia defined as pulse oximetry reading less than 95 percents | Intraoperatively , during induction of anaesthesia | 
| The use of any other airway adjunct or external laryngeal manipulation to assist in intubation | Change of blade size, bougie, magill forcep, video assisted laryngoscope,external laryngeal manipulation (Use of any airway adjunct is grouped as one) | Intraoperatively , during induction of anaesthesia | 
| Occurrence of esophageal intubation | Unsuccessful intubation into esophagus | Intraoperatively , during induction of anaesthesia | 
| Occurrence of airway trauma | broken tooth, bleeding or injury from oral cavity, tongue or lips, etc | Intraoperatively , during induction of anaesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid sequence induction, Bed up head elevation, sniffing position, cricoid pressure, time taken for intubation in seconds, percentage of glottic opening