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

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ClinicalTrials.gov Identifier: NCT03912935
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Shahmini a/p Ganesh, University of Malaya

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.


Condition or disease Intervention/treatment Phase
Endotracheal Intubation in Bed up Head Elevation Position in Rapid Sequence Induction Other: comparison between two different intubating position Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description: Only participant is masked from knowing the assigned group
Primary Purpose: Supportive Care
Official Title: Comparison of Bed up Head Elevated Position With Sniffing Position in Rapid Sequence Induction: a Randomised, Controlled, Non-inferiority Trial
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
No Intervention: Sniffing position
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
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
Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of laryngoscopy and intubation attempt [ Time Frame: Intraoperatively , during induction of anaesthesia ]
    Number of attempts taken by investigator to obtain successful endotracheal intubation in both arms

  2. Laryngeal exposure measured via POGO score [ Time Frame: Intraoperatively , during induction of anaesthesia ]
    Percentage of glottic opening during laryngoscopy

  3. Occurrence of difficult intubation [ Time Frame: Intraoperatively , during induction of anaesthesia ]
    Defined as ≥3 attempts at intubation

  4. Occurrence of hypoxia [ Time Frame: Intraoperatively , during induction of anaesthesia ]
    Hypoxia defined as pulse oximetry reading less than 95 percents

  5. The use of any other airway adjunct or external laryngeal manipulation to assist in intubation [ Time Frame: Intraoperatively , during induction of anaesthesia ]
    Change of blade size, bougie, magill forcep, video assisted laryngoscope,external laryngeal manipulation (Use of any airway adjunct is grouped as one)

  6. Occurrence of esophageal intubation [ Time Frame: Intraoperatively , during induction of anaesthesia ]
    Unsuccessful intubation into esophagus

  7. Occurrence of airway trauma [ Time Frame: Intraoperatively , during induction of anaesthesia ]
    broken tooth, bleeding or injury from oral cavity, tongue or lips, etc



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912935


Contacts
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Contact: Shahmini Ganesh, MD 0379492052 shahminig2805@gmail.com
Contact: Samuel Tsan Ern Hung, MD 0379492052 samuel.tsan@gmail.com

Locations
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Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
Contact: Shahmini Ganesh, MD    0379492052    shahminig2805@gmail.com   
Contact: Samuel Tsan Ern Hung, MD    0379492052    samuel.tsan@gmail.com   
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Shahmini Ganesh, MD UMMC

Publications:

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Responsible Party: Dr Shahmini a/p Ganesh, Principal Investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT03912935    
Other Study ID Numbers: MREC ID NO: 2018222-6042
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data that already summarized and analysed in the form of schematic diagram will be available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Shahmini a/p Ganesh, University of Malaya:
Rapid sequence induction
Bed up head elevation
sniffing position
cricoid pressure
time taken for intubation in seconds
percentage of glottic opening