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

Not Applicable

Completed

• Conditions: Bed up Head Elevated Intubation Position
• Interventions: Procedure: Tracheal intubation; Device: Bed up head elevated tracheal intubation; Device: Glidescope assisted tracheal intubation

• Registration Number: NCT03357679
• Lead Sponsor: University of Malaya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-11-30
• Study Start: 2017-12-26
• Status Verified: 2018-09
• Primary Completion: 2018-09-13
• Study Completion: 2018-09-13
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bed up head elevated intubation	Bed up head elevated tracheal intubation	Patients positioned in the bed up head elevated position, followed by tracheal intubation
Bed up head elevated intubation	Tracheal intubation	Patients positioned in the bed up head elevated position, followed by tracheal intubation
Glidescope assisted intubation	Tracheal intubation	Glidescope is used for laryngoscopy, followed by intubation
Glidescope assisted intubation	Glidescope assisted tracheal intubation	Glidescope is used for laryngoscopy, followed by intubation

Primary Outcome Measures

Name	Time	Method
Time required for intubation	Through study completion, period of 1 year	Measured from the time the tip of the laryngoscope passes through the incisors to the time of the first recorded wave of capnography
Laryngeal exposure	Through study completion, period of 1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia