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

NCT ID: NCT06327867

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-01

Brief Summary

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)

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

Conditions

To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Direct Laryngoscopy

All participants who are intubated from Direct laryngoscopy is enrolled in this arm.

Group Type: ACTIVE_COMPARATOR

Oro Tracheal Intubation by DL

Intervention Type: DEVICE

DL

Video Laryngoscopy

All participants who are intubated from Video laryngoscopy is enrolled in this arm.

Group Type: EXPERIMENTAL

Oro Tracheal Intubation by VL

Intervention Type: DEVICE

VL

Interventions

Oro Tracheal Intubation by DL

DL

Intervention Type: DEVICE

Oro Tracheal Intubation by VL

VL

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patan Academy of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Rony Maharjan

Doctor, Lecturer, Department of General practice and Emergency medicine, Priniciple Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rony Maharjan, MD

Role: PRINCIPAL_INVESTIGATOR

Patan Academy of Health Sciences

Central Contacts

Rony Maharjan, MD

Role: CONTACT

ronymaharjan@pahs.edu.np

9840728187

Kripa Maharjan, MD

Role: CONTACT

kripamaharjan@pahs.edu.np

9841837728

Other Identifiers

drs2402021836

Identifier Type: -

Identifier Source: org_study_id