Back to resultsComparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study
Primary Purpose
Obesity, Morbid, Intubation; Difficult or Failed, Video Laryngoscope
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
airtraq video laryngoscope
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity, Morbid
Eligibility Criteria
Inclusion Criteria:> 18 age men gender elective operation requring intuabtion - Exclusion Criteria:<18 age women emergency operation -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
morbidly obese
nonobese
Arm Description
Class 2 (bmı >35) weight kg/height m2 and class 3 (bmı>40) obese men
bmı<30 weight kg/ height m2 men
Outcomes
Primary Outcome Measures
intubation time
the intubation time will be recorded beginning the insertion of the Airtraq through the mouth still the endotracheal tube seen passing through the vocal cords
Secondary Outcome Measures
insertion time
inserting the Airtraq through the mouth till the optimal glottic vizualization occurred
peroperative hemodynamic variable
heart rate
Full Information
NCT ID
NCT05927519
First Posted
June 19, 2023
Last Updated
June 28, 2023
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT05927519
Brief Title
Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study
Official Title
Airtraq in Obese and Nonobese Men
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 5, 2023 (Anticipated)
Primary Completion Date
July 5, 2025 (Anticipated)
Study Completion Date
July 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, perioperative hemodynamic variables, and postoperative complications will also be recorded.
Detailed Description
Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, need of optimization menuvers, perioperative hemodynamic variables, and postoperative complications will also be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Intubation; Difficult or Failed, Video Laryngoscope, Men
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Airtraq video laryngoscope will be used in morbid obese and non obese patients
Masking
ParticipantOutcomes Assessor
Masking Description
the participant and the outcome assessor will not know which device was used in this trail
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
morbidly obese
Arm Type
Active Comparator
Arm Description
Class 2 (bmı >35) weight kg/height m2 and class 3 (bmı>40) obese men
Arm Title
nonobese
Arm Type
Placebo Comparator
Arm Description
bmı<30 weight kg/ height m2 men
Intervention Type
Device
Intervention Name(s)
airtraq video laryngoscope
Intervention Description
airtraq video laryngoscope will be used for intubations
Primary Outcome Measure Information:
Title
intubation time
Description
the intubation time will be recorded beginning the insertion of the Airtraq through the mouth still the endotracheal tube seen passing through the vocal cords
Time Frame
50 seconds
Secondary Outcome Measure Information:
Title
insertion time
Description
inserting the Airtraq through the mouth till the optimal glottic vizualization occurred
Time Frame
20 seconds
Title
peroperative hemodynamic variable
Description
heart rate
Time Frame
4 hours
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
men
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:> 18 age men gender elective operation requring intuabtion -
Exclusion Criteria:<18 age women emergency operation
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zehra Arslan, professor
Phone
00902623038168
Email
zehraipek48@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study
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