Comparison of laryngeal opening seen in bed-up-head-elevated position Macintosh laryngoscopy with conventional C-MAC video laryngoscopy

Phase 3

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/02/050036
• Lead Sponsor: Prashant Sirohiya

Brief Summary

Many difficult tracheal intubations are unanticipatedand can have catastrophic consequences. The patient’s position beforeintubation is of great importance in increasing the success rate of trachealintubation. The sniffing position is the most widely accepted position fortracheal intubation.  Lee etal studied the effects of 25 degrees of bed elevation to the supine positionand found better laryngeal visualization. Other researchers alsoshowed the effectiveness of bed-up-head–elevated (BUHE) position inendotracheal intubation (ETI) with increased success rates of trachealintubation, decreased airway complications, reduced need for airway adjuncts,decreased time to endotracheal intubation, and prolonged safe apnea time forintubation. Over the last many years, there has been increasing inthe use of video-assisted laryngoscopy (VAL) devices. Literature had showedthat VAL is associated with better laryngeal exposure and an increased successrate of endotracheal intubation. 10,11 The higher cost associatedwith VAL, especially in developing countries limits its use in patientsundergoing endotracheal intubations in a low-resource setting.

Currently, to our knowledge, no literature isthere that compared laryngoscopy in the BUHE position with conventional C-MAClaryngoscopy. We wish to perform a noninferiority trial comparing betweenMacintosh laryngoscopy in the BUHE position and laryngoscopy via conventionalC-MAC laryngoscopy in the supine position. Our primary objective is to determinewhether laryngeal exposure in the BUHE position Macintosh laryngoscopy is non-inferiorto conventional C-MAC laryngoscopy. We hypothesize that Macintosh laryngoscopyin the BUHE position provides noninferior laryngeal exposure when compared to conventionalC-MAC laryngoscopy in the supine position, within the bounds of the predefinedmargin of noninferiority set at −15%.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Study Completion: 2023-10-16
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status (PS) classification I to III.
• Planned for elective surgeries requiring ETI under general anesthesia (GA).
• Age Group: 18 to 65 years of age.

Exclusion Criteria

• Patients with ischemic heart disease, cerebrovascular disease, respiratory disease, or body mass index (BMI) >35 kg·m−2.
• In addition, patients who require rapid sequence induction or having airway obstruction, small mouth opening, or contraindication to neck extension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-To note down the change in laryngeal exposure (percentage of Glottic Opening {POGO} score	At baseline, the time of Laryngoscopy and intubation

Secondary Outcome Measures

Name	Time	Method
To compare in both groups-	•Cormack Lehane Grading

Trial Locations

Locations (1)

National Cancer Institute; 🇮🇳 Jhajjar, HARYANA, India

National Cancer Institute

🇮🇳Jhajjar, HARYANA, India

Dr Prashant Sirohiya

Principal investigator

8824090277

sirohiyaprashant@gmail.com