NCT02478203

Brief Summary

After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq, Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

April 17, 2015

Last Update Submit

February 2, 2017

Conditions

Difficult Intubation

Keywords

AirtraqGlidescopepediatricface-to-face

Outcome Measures

Primary Outcomes (1)

  • intubation time

    handling of the device till visualization of the tube entering through the vocal cords

    120 seconds

Secondary Outcomes (5)

  • need of maneuvers (mender applied or not)

    intraoperative

  • esophageal intubation (eosophageal intubation occured or not)

    intraoperative

  • intubation attempts (is it increased or not)

    intraoperative

  • cormack-lehane grade (which one improves the cormack- lehane grade)

    intraoperative

  • insertion time

    30 seconds

Study Arms (3)

normal

PLACEBO COMPARATOR

intubation of a normal airway pediatric manikin with direct laryngoscopy, airtraq , glidescope

Device: AirtraqDevice: GlidescopeDevice: direct laryngoscopy

tongue edema

ACTIVE COMPARATOR

intubation of a tongue edema simulated pediatric manikin with diract laryngoscopy, glidescope and airtraq

Device: AirtraqDevice: GlidescopeDevice: direct laryngoscopy

face-to-face intubation

ACTIVE COMPARATOR

intubation of an entrapped pediatric manikin with diract laryngoscopy, glidescope and airtraq

Device: AirtraqDevice: Glidescope

Interventions

AirtraqDEVICE

videolaryngoscope for difficult airway

face-to-face intubationnormaltongue edema
GlidescopeDEVICE

videolaryngoscope for difficult airway

face-to-face intubationnormaltongue edema
direct laryngoscopyDEVICE

gold standart for intubation

normaltongue edema

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric

You may not qualify if:

  • adult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

Location

Study Officials

  • Zehra I Arslan

    Anesthesiology and Reanimation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 17, 2015

First Posted

June 23, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 3, 2017

Record last verified: 2017-02

Locations

TU(1)