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

NCT ID: NCT05927519

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2027-10-05

Brief Summary

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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

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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.

Conditions

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Obesity, Morbid Intubation; Difficult or Failed Video Laryngoscope Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Airtraq video laryngoscope will be used in morbid obese and non obese patients
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

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

Study Groups

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morbidly obese

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

Group Type ACTIVE_COMPARATOR

airtraq video laryngoscope

Intervention Type DEVICE

airtraq video laryngoscope will be used for intubations

nonobese

bmı\<30 weight kg/ height m2 men

Group Type PLACEBO_COMPARATOR

airtraq video laryngoscope

Intervention Type DEVICE

airtraq video laryngoscope will be used for intubations

Interventions

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airtraq video laryngoscope

airtraq video laryngoscope will be used for intubations

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Ipek ARSLAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University Medical Faculty Hospital

Iamit, , Turkey (Türkiye)

Site Status RECRUITING

Kocaeli UniversityMedical Faculty

Kocaeli, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Zehra Arslan, professor

Role: CONTACT

00902623038168

Other Identifiers

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KAEK/10.bI.03

Identifier Type: -

Identifier Source: org_study_id

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