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

NCT03357679 | Completed

• 1 other identifier: 2017112-5770
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bed up Head Elevated Intubation Position

Keywords

Bed up head elevated position; Glidescope assisted tracheal intubation; Laryngeal exposure; Time to intubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of intubation attempts

  Through study completion, period of 1 year

• Effort during laryngoscopy

  Through study completion, period of 1 year

• Complications arising from intubation

  Through study completion, period of 1 year

• Airway trauma

  Through study completion, period of 1 year

Study Arms (2)

Bed up head elevated intubation

ACTIVE COMPARATOR

Patients positioned in the bed up head elevated position, followed by tracheal intubation

Procedure: Tracheal intubation; Device: Bed up head elevated tracheal intubation

Glidescope assisted intubation

ACTIVE COMPARATOR

Glidescope is used for laryngoscopy, followed by intubation

Procedure: Tracheal intubation; Device: Glidescope assisted tracheal intubation

Interventions

Tracheal intubation PROCEDURE

Intubation of the trachea with endotracheal tube

Bed up head elevated intubation; Glidescope assisted intubation

Glidescope assisted tracheal intubation DEVICE

With the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube

Glidescope assisted intubation

Bed up head elevated tracheal intubation DEVICE

Use of the Macintosh laryngoscope blade size 3

Bed up head elevated intubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 31348051 DERIVED

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Samuel E H Tsan, MD, BMedSc

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator is blinded to the initial laryngeal exposure during the sniffing position, but is unblinded during assessment of laryngeal exposure in either the bed up head elevated position or glidescope assisted tracheal intubation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 30, 2017
• Study Start: December 26, 2017
• Primary Completion: September 13, 2018
• Study Completion: September 13, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)