- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478203
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
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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