NCT04145089

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 8, 2020

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

October 28, 2019

Last Update Submit

July 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    Time taken from insertion of specified laryngoscope blade to lip until presence of capnography tracing

    5 minutes

Secondary Outcomes (1)

  • Cormack Lehane view

    5 minutes

Other Outcomes (2)

  • Additional maneuvre to assist intubation

    5 minutes

  • adverse events

    5 minutes

Study Arms (2)

C-Mac intubation

ACTIVE COMPARATOR

Intubation with C-MAC video laryngoscopy

Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy

Glidescope intubation

ACTIVE COMPARATOR

Intubation with Glidescope video laryngoscopy

Device: Glidescope video laryngoscopy/ C-MAC video laryngoscopy

Interventions

usage of said devices according to manual

C-Mac intubationGlidescope intubation

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusat Perubatan Universiti Kebangsaan Malaysia

Kuala Lumpur, 56000, Malaysia

Location

Related Publications (5)

  • Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.

    PMID: 19128325BACKGROUND
  • Armstrong J, John J, Karsli C. A comparison between the GlideScope Video Laryngoscope and direct laryngoscope in paediatric patients with difficult airways - a pilot study. Anaesthesia. 2010 Apr;65(4):353-7. doi: 10.1111/j.1365-2044.2010.06294.x.

    PMID: 20402873BACKGROUND
  • Mosier J, Chiu S, Patanwala AE, Sakles JC. A comparison of the GlideScope video laryngoscope to the C-MAC video laryngoscope for intubation in the emergency department. Ann Emerg Med. 2013 Apr;61(4):414-420.e1. doi: 10.1016/j.annemergmed.2012.11.001. Epub 2013 Jan 30.

    PMID: 23374414BACKGROUND
  • Hurford DM, White MC. A comparison of the Glidescope and Karl Storz DCI videolaryngoscopes in a paediatric manikin. Anaesthesia. 2010 Aug;65(8):781-4. doi: 10.1111/j.1365-2044.2010.06390.x. Epub 2010 Jun 2.

    PMID: 20528838BACKGROUND
  • Kim JT, Na HS, Bae JY, Kim DW, Kim HS, Kim CS, Kim SD. GlideScope video laryngoscope: a randomized clinical trial in 203 paediatric patients. Br J Anaesth. 2008 Oct;101(4):531-4. doi: 10.1093/bja/aen234. Epub 2008 Aug 8.

    PMID: 18689807BACKGROUND

Study Officials

  • Syarifah Noor Nazihah Sayed Masri, MD

    Universiti Kebangsaan Malaysia Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomization
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: GlideScope intubation Vs Cmac intubation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

June 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

July 8, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations