Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction.
NCT ID: NCT03912935
Last Updated: 2019-04-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
54 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-24
Study Completion Date
2019-06-30
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:
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.
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.
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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.
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.
Conditions
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Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
* 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.
* 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 Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Participants
Only participant is masked from knowing the assigned group
Study Groups
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Sniffing position
Subject will be maintained in standard intubation position which is supine position with head elevation with head rest (foam donut).
Group Type
NO_INTERVENTION
No interventions assigned to this group
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
Group Type
EXPERIMENTAL
comparison between two different intubating position
Intervention Type
OTHER
Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases
Interventions
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comparison between two different intubating position
Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases
Intervention Type
OTHER
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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Malaya
OTHER
Sponsor Role
lead
Responsible Party
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Dr Shahmini a/p Ganesh
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Shahmini Ganesh, MD
Role: PRINCIPAL_INVESTIGATOR
UMMC
Locations
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University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Site Status
RECRUITING
Countries
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Malaysia
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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MREC ID NO: 2018222-6042
Identifier Type: -
Identifier Source: org_study_id
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