- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02290249
Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq
Face-to-face Intubation With Glidescope or Airtraq
Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal.
Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six medical students who were on the beginning of their third year were enrolled in this study. After watching a video about the intubation of one of these devices, they attempted to intubate an adult manikin in three different airway models in a random order; first in normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- medical students at their third year,
- novice personnel
Exclusion Criteria:
- anesthesists,
- anesthesia residents,
- skilled investigators of tracheal intubation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: normal airway
İntubation with glidescope or airtraq in normal airway
|
Manikin was intubated by different novice personal with glidescope videolaryngoscope
Pediatric manikin was intubated by novice personal with airtraq
|
Active Comparator: tongue edema
intubation with glidescope or airtraq in tongue edema simulation
|
Manikin was intubated by different novice personal with glidescope videolaryngoscope
Pediatric manikin was intubated by novice personal with airtraq
|
Active Comparator: face-to-face
intubation with glidescope or airtraq in face-to-face intubation
|
Manikin was intubated by different novice personal with glidescope videolaryngoscope
Pediatric manikin was intubated by novice personal with airtraq
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intubation success rates
Time Frame: 5 minutes
|
We recorded the first and total intubation success rates of the intubation with one of these devices
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intubation time
Time Frame: 5 minutes
|
from the handling of the device till viewing the endotracheal tube entering the vocal cords
|
5 minutes
|
Esophageal intubation
Time Frame: 5 minutes
|
is there an esophageal intubation occurred while inserting the tube or not
|
5 minutes
|
need of optimisation maneuvers
Time Frame: 5 minutes
|
do we need an optimization maneuver while intubating or while viewing the glottis or not
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zehra I ARSLAN, Doctor, Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KOU KAEK 2014/145
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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