NCT04153370

Brief Summary

difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy. We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of \<1 year old children undergoing neurosurgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

November 4, 2019

Last Update Submit

February 19, 2020

Conditions

Infant Conditions

Keywords

airtraqglidescopec-macvideolaryngoscopeintubationinfant

Outcome Measures

Primary Outcomes (1)

  • intubation time

    device entering the oral cavity till visualization of the tube entering through the vocal cords

    40 seconds

Secondary Outcomes (1)

  • insertion time

    20 seconds

Study Arms (3)

intubation time airtraq

ACTIVE COMPARATOR

inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords

Device: Airtraq

intubation time glidescope

ACTIVE COMPARATOR

inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords

Device: glidescope

intubation time c-mac

ACTIVE COMPARATOR

inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords

Device: c-mac

Interventions

AirtraqDEVICE

airtraq video laryngoscope was used for intubation of the infant

Also known as: videolaryngoscope
intubation time airtraq
glidescopeDEVICE

glidescope video laryngoscope was used for intubation of the infant

Also known as: videolaryngoscope
intubation time glidescope
c-macDEVICE

c-mac video laryngoscope was used for intubation of the infant

Also known as: videolaryngoscope
intubation time c-mac

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age
  • undergoing neurosurgery
  • ASA 1-2

You may not qualify if:

  • cardiac problems
  • ASA 3-4
  • emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

November 5, 2019

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)