Clinical trial NCT03912935: Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction.
Official title: Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction
Keywords: Rapid sequence induction
Bed up head elevation
sniffing position
cricoid pressure
time taken for intubation in seconds
percentage of glottic opening
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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:

1. 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.
2. 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.
3. 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:

* 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in seconds measured from when the laryngoscopy blade passes through the incisors to the first measured end tidal CO2 wave
timeFrame: Intraoperatively , during induction of anaesthesia
Secondary outcomes:
measure: Number of laryngoscopy and intubation attempt
timeFrame: Intraoperatively , during induction of anaesthesia
measure: Laryngeal exposure measured via POGO score
timeFrame: Intraoperatively , during induction of anaesthesia
measure: Occurrence of difficult intubation
timeFrame: Intraoperatively , during induction of anaesthesia
measure: Occurrence of hypoxia
timeFrame: Intraoperatively , during induction of anaesthesia
measure: The use of any other airway adjunct or external laryngeal manipulation to assist in intubation
timeFrame: Intraoperatively , during induction of anaesthesia
measure: Occurrence of esophageal intubation
timeFrame: Intraoperatively , during induction of anaesthesia
measure: Occurrence of airway trauma
timeFrame: Intraoperatively , during induction of anaesthesia
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: UMMC
name: Shahmini Ganesh, MD
role: PRINCIPAL_INVESTIGATOR
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