Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study

Sponsor

Kocaeli University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05927519

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid Intubation; Difficult or Failed Video Laryngoscope Men	Device: airtraq video laryngoscope	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Airtraq video laryngoscope will be used in morbid obese and non obese patientsAirtraq video laryngoscope will be used in morbid obese and non obese patients

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

the participant and the outcome assessor will not know which device was used in this trail

Primary Purpose:

Diagnostic

Official Title:

Airtraq in Obese and Nonobese Men

Anticipated Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Jul 5, 2025

Anticipated Study Completion Date :

Jul 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: morbidly obese Class 2 (bmı >35) weight kg/height m2 and class 3 (bmı>40) obese men	Device: airtraq video laryngoscope airtraq video laryngoscope will be used for intubations
Placebo Comparator: nonobese bmı<30 weight kg/ height m2 men	Device: airtraq video laryngoscope airtraq video laryngoscope will be used for intubations

Arm

Intervention/Treatment

Active Comparator: morbidly obese

Class 2 (bmı >35) weight kg/height m2 and class 3 (bmı>40) obese men

Device: airtraq video laryngoscope

airtraq video laryngoscope will be used for intubations

Placebo Comparator: nonobese

bmı<30 weight kg/ height m2 men

Device: airtraq video laryngoscope

airtraq video laryngoscope will be used for intubations

Outcome Measures

Primary Outcome Measures

intubation time [50 seconds]
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 [20 seconds]
inserting the Airtraq through the mouth till the optimal glottic vizualization occurred
peroperative hemodynamic variable [4 hours]
heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:> 18 age men gender elective operation requring intuabtion -

Exclusion Criteria:<18 age women emergency operation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kocaeli University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zehra Ipek ARSLAN, Professor, Kocaeli University

ClinicalTrials.gov Identifier:

NCT05927519

Other Study ID Numbers:

KAEK/10.bI.03

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of Jul 3, 2023