Tracheal Intubation in Morbidly Obese (BMI>35) and in Lean (BMI<30) Patients Using McGrath MAC X-Blade

March 3, 2020 updated by: Zehra Ipek ARSLAN, Kocaeli University

A Comparison of Morbidly Obese and Lean

80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients and insertion and intubation times with these dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative complications were recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients were recorded. Airway management variables Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers ( cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness were recorded.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Turkey
      • Kocaeli, Turkey
        • Kocaeli University Medical Faculty
      • Kocaeli, Turkey, 41900
        • Kocaeli University School of Medicine

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: > 18 age <65 age

  • bmı 35

    • undergoing elective surgery requiring endotracheal intubation

Exclusion Criteria: -pregnant

  • <18 and >65 years of age
  • bmı<35
  • upper respiratory tract infection past ten days

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: insertion time
Device: lean
Videolaryngoscope used in intubation
Device: obese
Videolaryngoscope used in intubation
Active Comparator: intubation time
Device: lean
Videolaryngoscope used in intubation
Device: obese
Videolaryngoscope used in intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intubation time
Time Frame: 2 months
2 months

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)

August 1, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOU-KAEK 2018 - 202

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

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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