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

NCT05927519 | Recruiting

• 1 other identifier: KAEK/10.bI.03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity, Morbid; Intubation; Difficult or Failed; Video Laryngoscope; Men

Outcome Measures

Primary Outcomes (1)

• 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

  50 seconds

Secondary Outcomes (2)

• insertion time

  20 seconds

• peroperative hemodynamic variable

  4 hours

Study Arms (2)

morbidly obese

ACTIVE COMPARATOR

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

Device: airtraq video laryngoscope

nonobese

PLACEBO COMPARATOR

bmı\<30 weight kg/ height m2 men

Device: airtraq video laryngoscope

Interventions

airtraq video laryngoscope DEVICE

airtraq video laryngoscope will be used for intubations

morbidly obese; nonobese

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (2)

Kocaeli University Medical Faculty Hospital

Iamit, 41100, Turkey (Türkiye)

RECRUITING

Kocaeli UniversityMedical Faculty

Kocaeli, 41100, Turkey (Türkiye)

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Central Study Contacts

Zehra Arslan, professor

CONTACT

00902623038168; zehraipek48@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the participant and the outcome assessor will not know which device was used in this trail
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Airtraq video laryngoscope will be used in morbid obese and non obese patients

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 3, 2023
• Study Start: October 25, 2024
• Primary Completion (Estimated): October 5, 2027
• Study Completion (Estimated): October 5, 2027
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)