ClinicalTrials.gg
Not yet recruitingNCT06327867Updated Apr 11, 2024

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

An interventional study of Oro Tracheal Intubation by DL and Oro Tracheal Intubation by VL in To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy, sponsored by Patan Academy of Health Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Patan Academy of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)
Read the 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

02

Conditions studied

  • To Compare Success Rate of Video Laryngoscopy vs Direct Laryngoscopy

Keywords

  • Video Laryngoscope, Direct Laryngoscope
03

In context

Lead sponsor

Patan Academy of Health Sciences is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Intubations done by medical officers
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • Active comparator
    Direct Laryngoscopy

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

    Device: Oro Tracheal Intubation by DL

  • Experimental
    Video Laryngoscopy

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

    Device: Oro Tracheal Intubation by VL

Interventions

  • DeviceOro Tracheal Intubation by DL

    DL

  • DeviceOro Tracheal Intubation by VL

    VL

06

What researchers measure

Primary outcomes

  1. First pass success of direct laryngoscopy in oro tracheal intubation

    success of oro tracheal intubation during DL

    Time frame: 1 year

  2. First pass success of video laryngoscopy in oro tracheal intubation

    success of oro tracheal intubation during VL

    Time frame: 1 year

Secondary outcomes

  1. Complications rates between two methods.

    rate of complication during intubation via DL or VL will be noted

    Time frame: 1 year

  2. Use of alternative methods for ventilation or oxygenation between two methods

    use of alternative methods during intubation via DL or VL will be noted

    Time frame: 1 year

  3. Better visualization of Cormack-Lehane grading between two methods

    better visualization of cormack lehane grading during intubation via DL or VL will be noted

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06327867
Lead sponsor
Patan Academy of Health Sciences
Responsible party
Rony Maharjan (Doctor, Lecturer, Department of General practice and Emergency medicine, Priniciple Investigator, Patan Academy of Health Sciences) — Principal investigator
First posted
Mar 25, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Mar 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Apr 11, 2024

Study contacts

Rony Maharjan, MD
Contact
ronymaharjan@pahs.edu.np
9840728187
Kripa Maharjan, MD
Contact
kripamaharjan@pahs.edu.np
9841837728
Rony Maharjan, MD
principal investigator · Patan Academy of Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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