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

October 24, 2024 updated by: Zehra Ipek ARSLAN, Kocaeli University

Airtraq in Obese and Nonobese Men

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

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 Contact

Study Locations

  • Turkey
      • Iamit, Turkey, 41100
        • Recruiting
        • Kocaeli University Medical Faculty Hospital
      • Kocaeli, Turkey, 41100
        • Active, not recruiting
        • Kocaeli UniversityMedical Faculty

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:<18 age women emergency operation

-

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: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation time
Time Frame: 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
50 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: 20 seconds
inserting the Airtraq through the mouth till the optimal glottic vizualization occurred
20 seconds
peroperative hemodynamic variable
Time Frame: 4 hours
heart rate
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

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 (Actual)

October 25, 2024

Primary Completion (Estimated)

October 5, 2027

Study Completion (Estimated)

October 5, 2027

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK/10.bI.03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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