Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope

February 2, 2017 updated by: Zehra Ipek ARSLAN, Kocaeli University

Intubation on a Pediatric Manikin by Emergency Medical Staff: a Comparison of Direct Laryngoscopy, Airtraq and Glidescope in Normal, Tongue Edema and Face-to-face Intubation Models

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.

Study Overview

Detailed Description

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; normal airway, tongue edema and an entrapped model by face-to-face approach. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades and the need for maneuvers of these devices were recorded.

Study Type

Interventional

Enrollment (Actual)

13

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

      • Kocaeli, Turkey, 41900
        • Kocaeli University School of Medicine

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

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pediatric

Exclusion Criteria:

  • adult

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: normal
intubation of a normal airway pediatric manikin with direct laryngoscopy, airtraq , glidescope
videolaryngoscope for difficult airway
videolaryngoscope for difficult airway
gold standart for intubation
Active Comparator: tongue edema
intubation of a tongue edema simulated pediatric manikin with diract laryngoscopy, glidescope and airtraq
videolaryngoscope for difficult airway
videolaryngoscope for difficult airway
gold standart for intubation
Active Comparator: face-to-face intubation
intubation of an entrapped pediatric manikin with diract laryngoscopy, glidescope and airtraq
videolaryngoscope for difficult airway
videolaryngoscope for difficult airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation time
Time Frame: 120 seconds
handling of the device till visualization of the tube entering through the vocal cords
120 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need of maneuvers (mender applied or not)
Time Frame: intraoperative
maneuver applied or not
intraoperative
esophageal intubation (eosophageal intubation occured or not)
Time Frame: intraoperative
eosophageal intubation occured or not
intraoperative
intubation attempts (is it increased or not)
Time Frame: intraoperative
the patient intubated at which attempt?
intraoperative
cormack-lehane grade (which one improves the cormack- lehane grade)
Time Frame: intraoperative
intraoperative
insertion time
Time Frame: 30 seconds
handling of the device till the glottic visualization
30 seconds

Collaborators and Investigators

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

Investigators

  • Study Director: Zehra I Arslan, Anesthesiology and Reanimation

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

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOU KAEK 2014/108

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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