NCT04153357

Brief Summary

İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

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

Click on a node to explore related trials.

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

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

November 4, 2019

Last Update Submit

March 17, 2023

Conditions

Intubation;Difficult

Keywords

airtraqc-macvideolaryngoscopeinfantintubatioon

Outcome Measures

Primary Outcomes (1)

  • intubation time

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

    30 seconds

Study Arms (2)

intubation time airtraq

ACTIVE COMPARATOR

intubation time of Airtraq

Device: airtraq

intubation time of c-mac

ACTIVE COMPARATOR

intubation time of c-mac

Device: c-mac

Interventions

airtraqDEVICE

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

Also known as: videolaryngoscope
intubation time airtraq
c-macDEVICE

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

Also known as: videolaryngoscope
intubation time of c-mac

Eligibility Criteria

Age1 Month - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \< 1 years old
  • undergoing neurosurgery ASA 1-2

You may not qualify if:

  • \> 1 year old
  • 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

March 21, 2023

Record last verified: 2023-03

Locations

TU(1)