Back to resultsIntubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope
Primary Purpose
Difficult Intubation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Airtraq
Glidescope
direct laryngoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Difficult Intubation focused on measuring Airtraq, Glidescope, pediatric, face-to-face
Eligibility Criteria
Inclusion Criteria:
- pediatric
Exclusion Criteria:
- adult
Sites / Locations
- Kocaeli University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
normal
tongue edema
face-to-face intubation
Arm Description
intubation of a normal airway pediatric manikin with direct laryngoscopy, airtraq , glidescope
intubation of a tongue edema simulated pediatric manikin with diract laryngoscopy, glidescope and airtraq
intubation of an entrapped pediatric manikin with diract laryngoscopy, glidescope and airtraq
Outcomes
Primary Outcome Measures
intubation time
handling of the device till visualization of the tube entering through the vocal cords
Secondary Outcome Measures
need of maneuvers (mender applied or not)
maneuver applied or not
esophageal intubation (eosophageal intubation occured or not)
eosophageal intubation occured or not
intubation attempts (is it increased or not)
the patient intubated at which attempt?
cormack-lehane grade (which one improves the cormack- lehane grade)
insertion time
handling of the device till the glottic visualization
Full Information
NCT ID
NCT02478203
First Posted
April 17, 2015
Last Updated
February 2, 2017
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT02478203
Brief Title
Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Intubation
Keywords
Airtraq, Glidescope, pediatric, face-to-face
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal
Arm Type
Placebo Comparator
Arm Description
intubation of a normal airway pediatric manikin with direct laryngoscopy, airtraq , glidescope
Arm Title
tongue edema
Arm Type
Active Comparator
Arm Description
intubation of a tongue edema simulated pediatric manikin with diract laryngoscopy, glidescope and airtraq
Arm Title
face-to-face intubation
Arm Type
Active Comparator
Arm Description
intubation of an entrapped pediatric manikin with diract laryngoscopy, glidescope and airtraq
Intervention Type
Device
Intervention Name(s)
Airtraq
Intervention Description
videolaryngoscope for difficult airway
Intervention Type
Device
Intervention Name(s)
Glidescope
Intervention Description
videolaryngoscope for difficult airway
Intervention Type
Device
Intervention Name(s)
direct laryngoscopy
Intervention Description
gold standart for intubation
Primary Outcome Measure Information:
Title
intubation time
Description
handling of the device till visualization of the tube entering through the vocal cords
Time Frame
120 seconds
Secondary Outcome Measure Information:
Title
need of maneuvers (mender applied or not)
Description
maneuver applied or not
Time Frame
intraoperative
Title
esophageal intubation (eosophageal intubation occured or not)
Description
eosophageal intubation occured or not
Time Frame
intraoperative
Title
intubation attempts (is it increased or not)
Description
the patient intubated at which attempt?
Time Frame
intraoperative
Title
cormack-lehane grade (which one improves the cormack- lehane grade)
Time Frame
intraoperative
Title
insertion time
Description
handling of the device till the glottic visualization
Time Frame
30 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pediatric
Exclusion Criteria:
adult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra I Arslan
Organizational Affiliation
Anesthesiology and Reanimation
Official's Role
Study Director
Facility Information:
Facility Name
Kocaeli University School of Medicine
City
Kocaeli
ZIP/Postal Code
41900
Country
Turkey
12. IPD Sharing Statement
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Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope
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