Video Laryngoscopy vs Direct Laryngoscopy in Paediatric Patients

May 25, 2024 updated by: Muhammad Ilyas, Watim Medical & Dental College

Video Laryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatrics Anesthesia, Comparison of Out-comes

The goal of this interventional study is to compare the effectiveness of direct laryngoscopy vs. video laryngoscopy in paediatric population aged 2 to 8 years presenting for elective surgeries having uncomplicated airways.

The primary outcome measures include:

  1. Time taken for succesful insertion and confirmation of ETT in patients using both techniques seprately.
  2. Rate of complications and failed attempts compared between both modalities.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The comparision of efficacy of Video Laryngoscopy for pediatric airway vs Direct Laryngoscopy is the goal of this study, Safety of the patients will be the utmost priority with careful case selection alongwith proper informed detailed consent from the guardians of the children.

PROCEDURE:

After induction of General Anesthesia four minutes of proper bag mask ventilation to allow for proper intubating conditions will be done. The time taken from the insertion of the laryngoscopic blade to the best glottic view acheived by the specific technique will be noted seperately and then the time to the succesful acheivement of lung inflation with the proper placement of ETT will be noted seperately, both of these parameters will be recorded.

If in a patient airway is not secured even after 3 attempts by a specific technique the technique would be altered and patient would be excluded from our research.

MATERIALS:

Randomized allotment of patients into the 2 groups i.e Direct Laryngoscopy and Video Laryngoscopy would be done.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Combined Millitary Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pediatric patients of age between 2 - 8 years,
  • American Society of Anesthesiologist (ASA) grades I-II Children
  • Cormack-Lehane grade I, II and III who will need airway management for elective surgery under general anesthesia.

Exclusion Criteria:

  • Patients with abnormal airway anatomy,
  • Obese patients,
  • Emergency surgery,
  • Congenital syndrome involving any major organs
  • Patients' guardians unwilling to participate .
  • Patients in whom airway is not secured with a specific technique even after three attempts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct Laryngoscopy Group
Group of patients in which standard direct laryngoscopy will be used to secure airway.
Device: Direct laryngoscope
Macintosh or Miller's laryngoscopes used to secure paediatric airways
Active Comparator: Video Laryngoscopy group
Group of patients in which Video Laryngoscopy will be used to secure airways.
Device: Video Laryngoscope
Use of Video laryngoscope to secure airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
.Time taken to acheive the best possible view of the glottis.
Time Frame: 4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration
The time from insertion of laryngoscope in the mouth to the best possible view of the glottis.
4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration
Time taken to acheive succesful Endotracheal Intubation.
Time Frame: 4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.
The time from the insertion of the laryngoscopic blade in the mouth to the correct placement of ETT confirmed by the waveform capnorgraphy.
4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.
No. of Intubation attempts needed
Time Frame: 4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.
Total No. of attempts(max 3 attempts with the same technique) to secure airway.
4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic changes at different intervals.
Time Frame: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Changes in heart rate will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.
During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Hemodynamic changes at different intervals.
Time Frame: During attempts to 1 min, 5 min, and 10 min post succesful intubation.
Changes in blood pressure will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.
During attempts to 1 min, 5 min, and 10 min post succesful intubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watim Medical & Dental College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

May 25, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CMH/614

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The outcomes of the study will be shared eventually once concluded

IPD Sharing Time Frame

Undecided

IPD Sharing Access Criteria

not yet Decided

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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