Comparison of Time Taken for Intubation and Cormack Lehane View Between C-Mac With Glidescope Video Laryngoscopy in Paediatric Patients

July 5, 2020 updated by: Universiti Kebangsaan Malaysia Medical Centre

Comparative Study of Time Taken for Intubation and Cormack Lehane View Between C-Mac Video Laryngoscopy With Glidescope Video Laryngoscopy in Paediatric Patients Undergoing Elective Surgery

This study compares the time taken to intubate between Cmac video laryngoscopy with Glidescope video laryngoscopy in paediatric patients aged 3-12 years old.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine whether are both devices comparable to each other in terms of intubation time and Cormack Lehane view in paediatric patients with normal airway undergoing elective surgery.

Study Type

Interventional

Enrollment (Actual)

64

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 Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 56000
        • Pusat Perubatan Universiti Kebangsaan Malaysia

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

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Paediatric patients 3-12 years old undergoing elective surgery
  • American Society of Anesthesiology (ASA) 1-2
  • No difficult airway features/history of difficult intubation
  • Not obese

Exclusion Criteria:

  • Any difficult intubation features/history of difficult intubation
  • Obese child

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: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: C-Mac intubation
Intubation with C-MAC video laryngoscopy
Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy
usage of said devices according to manual
Active Comparator: Glidescope intubation
Intubation with Glidescope video laryngoscopy
Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy
usage of said devices according to manual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: 5 minutes
Time taken from insertion of specified laryngoscope blade to lip until presence of capnography tracing
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cormack Lehane view
Time Frame: 5 minutes
grade from 1-4 by operator's assesment
5 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional maneuvre to assist intubation
Time Frame: 5 minutes
i.e external laryngeal manipulation, bougie assisted
5 minutes
adverse events
Time Frame: 5 minutes
i.e lip injury, desaturations
5 minutes

Collaborators and Investigators

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

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Principal Investigator: Syarifah Noor Nazihah Sayed Masri, MD, Universiti Kebangsaan Malaysia Medical Centre

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 (Actual)

June 1, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 5, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • FF-2019-004

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

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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