Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation

Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation: A Randomised, Controlled, Non-inferiority Trial

Positioning during the process of tracheal intubation is critical, as optimal positioning can greatly facilitate successful intubation. Many complications can occur as a result of failed intubation, ranging from airway injury, lack of oxygen, with even deaths. Today, the most popular positioning of patients for intubation is in the "sniffing" position. There is however evidence to support that intubation in the bed-up-head-elevated position may be better. In today's technological age, video assisted laryngoscopy (Laryngoscopy is the process of visualizing the vocal cords prior to intubation), a new method where the anaesthetist intubates a patient via aid of an image guided view of the airway, is increasingly popular due to its reliability and superiority to normal intubation. However, it is not widely available, and may suffer from technical breakdowns. The Glidescope is one example of a video laryngoscope, and has been widely researched in the medical literature. In this study, the investigators wish to investigate whether intubation in the bed-up-head-elevated position will be as good as, if not better than Glidescope assisted tracheal intubation, in patients undergoing elective surgery and planned for general anaesthesia.

Study Overview

• Status: Completed
• Conditions: Bed up Head Elevated Intubation Position
• Intervention / Treatment: Procedure: Tracheal intubation; Device: Bed up head elevated tracheal intubation; Device: Glidescope assisted tracheal intubation

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
      • University Malaya Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients undergoing elective surgeries under general anaesthesia
2. Patients aged from 18 years old to 75 years old
3. Patients who are able to give informed consent

Exclusion Criteria:

1. Patients with airway obstruction
2. Patients with contraindications to neck extension
3. Patients with small mouth opening (<3 cm)
4. BMI > 35 kg/m3
5. Patients with ischemic heart disease, cerebrovascular disease and respiratory diseases
6. Patients in whom rapid sequence induction is indicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bed up head elevated intubation; Patients positioned in the bed up head elevated position, followed by tracheal intubation	Procedure: Tracheal intubation; Intubation of the trachea with endotracheal tube; Device: Bed up head elevated tracheal intubation; Use of the Macintosh laryngoscope blade size 3
Active Comparator: Glidescope assisted intubation; Glidescope is used for laryngoscopy, followed by intubation	Procedure: Tracheal intubation; Intubation of the trachea with endotracheal tube; Device: Glidescope assisted tracheal intubation; With the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laryngeal exposure	Measured by Percentage of Glottic Opening (POGO) score. A 100% POGO score refers to visualisation of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% refers to no visualisation of laryngeal structures. A 100% score is optimal.	Through study completion, period of 1 year
Time required for intubation	Measured from the time the tip of the laryngoscope passes through the incisors to the time of the first recorded wave of capnography	Through study completion, period of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts		Through study completion, period of 1 year
Effort during laryngoscopy	Assessed based on a visual analogue scale, with 10 being the strongest effort, and 1 being the least effort required.	Through study completion, period of 1 year
Complications arising from intubation	Incidence of hypoxia, hypotension, or esophageal intubation. Yes/no categories.	Through study completion, period of 1 year
Airway trauma	Whether injury occurs to the lips, tongue, teeth, and other structures in the oropharyngeal area. Yes/no categories.	Through study completion, period of 1 year

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Samuel E H Tsan, MD, BMedSc, University of Malaya

Publications and helpful links

General Publications

• Tsan SEH, Lim SM, Abidin MFZ, Ganesh S, Wang CY. Comparison of Macintosh Laryngoscopy in Bed-up-Head-Elevated Position With GlideScope Laryngoscopy: A Randomized, Controlled, Noninferiority Trial. Anesth Analg. 2020 Jul;131(1):210-219. doi: 10.1213/ANE.0000000000004349.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2017
• Primary Completion (Actual): September 13, 2018
• Study Completion (Actual): September 13, 2018

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Bed up head elevated position; Glidescope assisted tracheal intubation; Laryngeal exposure; Time to intubation
• Other Study ID Numbers: 2017112-5770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No