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

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lean
obese
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity, Morbid focused on measuring videolaryngoscope, Airtraq, McGrath MAC, Morbid obesity, intubation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kocaeli University School of Medicine
  • Kocaeli University Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

insertion time

intubation time

Arm Description

Outcomes

Primary Outcome Measures

intubation time

Secondary Outcome Measures

Full Information

First Posted
November 29, 2018
Last Updated
March 3, 2020
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT03759990
Brief Title
Tracheal Intubation in Morbidly Obese (BMI>35) and in Lean (BMI<30) Patients Using McGrath MAC X-Blade
Official Title
A Comparison of Morbidly Obese and Lean
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
videolaryngoscope, Airtraq, McGrath MAC, Morbid obesity, intubation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insertion time
Arm Type
Active Comparator
Arm Title
intubation time
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
lean
Intervention Description
Videolaryngoscope used in intubation
Intervention Type
Device
Intervention Name(s)
obese
Intervention Description
Videolaryngoscope used in intubation
Primary Outcome Measure Information:
Title
intubation time
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kocaeli University School of Medicine
City
Kocaeli
ZIP/Postal Code
41900
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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