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

NCT ID: NCT03357679

Last Updated: 2018-09-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-26

Study Completion Date

2018-09-13

Brief Summary

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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.

Detailed Description

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Conditions

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Bed up Head Elevated Intubation Position

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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

Study Groups

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Bed up head elevated intubation

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

Group Type ACTIVE_COMPARATOR

Tracheal intubation

Intervention Type PROCEDURE

Intubation of the trachea with endotracheal tube

Bed up head elevated tracheal intubation

Intervention Type DEVICE

Use of the Macintosh laryngoscope blade size 3

Glidescope assisted intubation

Glidescope is used for laryngoscopy, followed by intubation

Group Type ACTIVE_COMPARATOR

Tracheal intubation

Intervention Type PROCEDURE

Intubation of the trachea with endotracheal tube

Glidescope assisted tracheal intubation

Intervention Type DEVICE

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

Interventions

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Tracheal intubation

Intubation of the trachea with endotracheal tube

Intervention Type PROCEDURE

Glidescope assisted tracheal intubation

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

Intervention Type DEVICE

Bed up head elevated tracheal intubation

Use of the Macintosh laryngoscope blade size 3

Intervention Type DEVICE

Eligibility Criteria

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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
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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Samuel E H Tsan, MD, BMedSc

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel E H Tsan, MD, BMedSc

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type DERIVED
PMID: 31348051 (View on PubMed)

Other Identifiers

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2017112-5770

Identifier Type: -

Identifier Source: org_study_id

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