Comparison of Video Laryngoscopy Versus Direct Laryngoscopy for Orotracheal Intubation Among Adults in Emergency Department

This is an open-label, single center, prospective, randomized, comparative, intervention study.

The goal of this study is to compare the success rate of video laryngoscopy vs direct laryngoscopy for first pass oro tracheal intubation. The other question it aims to answer are:

1. To assess the adverse events during video laryngoscopy
2. To assess the adverse events during direct Laryngoscopy
3. To compare the first pass success rate of DL vs VL according to demographic profile (age and sex)

Study Overview

• Status: Not yet recruiting
• Conditions: To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy
• Intervention / Treatment: Device: Oro Tracheal Intubation by DL; Device: Oro Tracheal Intubation by VL

Detailed Description

All consecutive patients presenting in Emergency medicine room requiring intubation, will be recruited in this study after taking informed written consent from the patients' family, excluding those falling in exclusion criteria. Direct laryngoscopy will be done by Mackintosh Laryngoscope with blade no 3 or 4. Video Laryngoscopy will be done by Mcgrath Mac Video Laryngoscope in respective groups. Intubations will be done by ER physicians and Emergency fellows of Emergency department. The total number of required sample size will be calculated and the obtained number will be divided in a group of 21 with block of 6 each. After randomizing the group and the block from a computerized software, a total of 21 envelope will be prepared in a consecutive manner and the patient will be intubated as per the pre decided blocks. All the patients in emergency who require intubation and falling into the inclusion criteria will be assessed. Informed written consent will be taken from the patient's family explaining that they will be a part of study and either of the laryngoscopy method will be used in them. Informed consent will be taken by one of the investigators, (ER physicians and emergency medicine fellow) who will be performing intubations in them.Inclusion criteria-

• Age 18 years
• Patient requiring orotracheal intubation
• Those who give written informed consent

Exclusion criteria-

• Pregnancy
• Intubations done by medical officers

Randomization-

• The consecutive patients will be assigned numbers serially from one.
• Block randomization of the patients in two arms will be done by using computerized software.

A total of 63 patients in each arm with total 126 patients will be included in the study. Blocks of 6 will be taken with total 21 groups. With using the software, random group will be selected and intubations will be done accordingly.

Demographic and clinical profile of patients in both arms will be recorded. Two treatment arms-

• Arm A- Orotracheal intubation done by Direct Laryngoscopy
• Arm B- Orotracheal intubation done by Video Laryngoscopy

Outcomes Primary- First pass success of direct laryngoscopy in oro tracheal intubation First pass success of video laryngoscopy in oro tracheal intubation

Secondary- Complications rates between two methods. Use of alternative methods for ventilation or oxygenation between two methods Better visualization of Cormack-Lehane grading between two methods

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rony Maharjan, MD; Phone Number: 9840728187; Email: ronymaharjan@pahs.edu.np
• Study Contact Backup: Name: Kripa Maharjan, MD; Phone Number: 9841837728; Email: kripamaharjan@pahs.edu.np

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years
2. Patient requiring orotracheal intubation
3. Those who give written informed consent

Exclusion Criteria:

1. Pregnancy
2. Intubations done by medical officers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct Laryngoscopy; All participants who are intubated from Direct laryngoscopy is enrolled in this arm.	Device: Oro Tracheal Intubation by DL; DL
Experimental: Video Laryngoscopy; All participants who are intubated from Video laryngoscopy is enrolled in this arm.	Device: Oro Tracheal Intubation by VL; VL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First pass success of direct laryngoscopy in oro tracheal intubation	success of oro tracheal intubation during DL	1 year
First pass success of video laryngoscopy in oro tracheal intubation	success of oro tracheal intubation during VL	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications rates between two methods.	rate of complication during intubation via DL or VL will be noted	1 year
Use of alternative methods for ventilation or oxygenation between two methods	use of alternative methods during intubation via DL or VL will be noted	1 year
Better visualization of Cormack-Lehane grading between two methods	better visualization of cormack lehane grading during intubation via DL or VL will be noted	1 year

Collaborators and Investigators

• Sponsor: Patan Academy of Health Sciences
• Investigators: Principal Investigator: Rony Maharjan, MD, Patan Academy of Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Video Laryngoscope, Direct Laryngoscope
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: drs2402021836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No