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

Study Overview
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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.

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

Conditions
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Bed up Head Elevated Intubation Position

Intervention / Treatment
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* Procedure: Tracheal intubation
* Device: Glidescope assisted tracheal intubation
* Device: Bed up head elevated tracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bed up head elevated position, Glidescope assisted tracheal intubation, Laryngeal exposure, Time to intubation