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

NCT06327867 | Not Yet Recruiting DMC

• 1 other identifier: drs2402021836
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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

Conditions

To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy

Keywords

Video Laryngoscope, Direct Laryngoscope

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Complications rates between two methods.

  1 year

• Use of alternative methods for ventilation or oxygenation between two methods

  1 year

• Better visualization of Cormack-Lehane grading between two methods

  1 year

Study Arms (2)

Direct Laryngoscopy

ACTIVE COMPARATOR

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

Device: Oro Tracheal Intubation by DL

Video Laryngoscopy

EXPERIMENTAL

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

Device: Oro Tracheal Intubation by VL

Interventions

Oro Tracheal Intubation by DL DEVICE

DL

Direct Laryngoscopy

Oro Tracheal Intubation by VL DEVICE

VL

Video Laryngoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Intubations done by medical officers

Sponsors & Collaborators

• Patan Academy of Health Sciences: lead

Study Officials

• Rony Maharjan, MD

  Patan Academy of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rony Maharjan, MD

CONTACT

9840728187; ronymaharjan@pahs.edu.np

Kripa Maharjan, MD

CONTACT

9841837728; kripamaharjan@pahs.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Lecturer, Department of General practice and Emergency medicine, Priniciple Investigator

Model Details: An open-label, single center, prospective, randomized, comparative, intervention study.

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share