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A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients (mcgrath&cmac)

Primary Purpose

Difficult Intubation, Morbid Obesity, Videolaryngoscopy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
C-MAC videolaryngoscope
McGrath MAC videolaryngoscope
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Difficult Intubation focused on measuring Morbidly Obese, Difficult Airway Management, Videolaryngoscopy

Eligibility Criteria

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

Inclusion Criteria:

  • American Society of Anesthesiology score III,
  • 18-65 years,
  • BMI> 40

Exclusion Criteria:

  • American Society of Anesthesiology IV,
  • Under 18 years,
  • Over 65 years,
  • Under BMI<40
  • Obstetric patients,
  • Uncontrolled cerebrovascular disease,
  • Patients who refused written informed consent forms

Sites / Locations

  • Sedat AKBAS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

C-MAC Videolaryngoscope

McGrath MAC Videolaryngoscope

Arm Description

Morbidly obese patients intubated with C-MAC Videolaryngoscope

Morbidly obese patients intubated with McGrath MAC Videolaryngoscope

Outcomes

Primary Outcome Measures

Time to intubation
Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords

Secondary Outcome Measures

Heart Rate
Heart Rate
Mean Arterial Pressure
Mean Arterial Pressure
Adverse Events
Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache

Full Information

First Posted
August 7, 2018
Last Updated
January 4, 2019
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03657927
Brief Title
A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients
Acronym
mcgrath&cmac
Official Title
A Comparison of McGrath® MAC Versus C-MAC® Videolaryngoscopes in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized, Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 8, 2018 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation of expected difficult airway management such as morbidly obese patients. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and complications related intubation of morbidly obese patients undergoing bariatric surgery.
Detailed Description
It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk. Mask ventilation and tracheal intubation in morbidly obese patients can be difficult with the anatomical changes caused by obesity. Reduced functional residual capacity in morbidly obese patients makes it difficult to maintain peripheral oxygen saturation at normal limits. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation. The use of videolaryngoscope in patients with difficult intubation such as morbid obesity, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of morbidly obese patients undergoing bariatric surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Intubation, Morbid Obesity, Videolaryngoscopy
Keywords
Morbidly Obese, Difficult Airway Management, Videolaryngoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C-MAC Videolaryngoscope
Arm Type
Active Comparator
Arm Description
Morbidly obese patients intubated with C-MAC Videolaryngoscope
Arm Title
McGrath MAC Videolaryngoscope
Arm Type
Active Comparator
Arm Description
Morbidly obese patients intubated with McGrath MAC Videolaryngoscope
Intervention Type
Device
Intervention Name(s)
C-MAC videolaryngoscope
Intervention Description
An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
Intervention Type
Device
Intervention Name(s)
McGrath MAC videolaryngoscope
Intervention Description
An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.
Primary Outcome Measure Information:
Title
Time to intubation
Description
Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords
Time Frame
From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Secondary Outcome Measure Information:
Title
Heart Rate
Description
Heart Rate
Time Frame
From beginning of Anesthesia induction to 5th minutes of intubation
Title
Mean Arterial Pressure
Description
Mean Arterial Pressure
Time Frame
From beginning of Anesthesia induction to 5th minutes of intubation
Title
Adverse Events
Description
Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache
Time Frame
During the first 24 hour postoperatively

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: American Society of Anesthesiology score III, 18-65 years, BMI> 40 Exclusion Criteria: American Society of Anesthesiology IV, Under 18 years, Over 65 years, Under BMI<40 Obstetric patients, Uncontrolled cerebrovascular disease, Patients who refused written informed consent forms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sedat Akbas
Organizational Affiliation
Inonu University Medical Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Sedat AKBAS
City
Malatya
State/Province
Türkiye-Türkçe
ZIP/Postal Code
44090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24643921
Citation
Gaszynski T. Clinical experience with the C-Mac videolaryngoscope in morbidly obese patients. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):14-6. doi: 10.5603/AIT.2014.0003.
Results Reference
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PubMed Identifier
23121470
Citation
Taylor AM, Peck M, Launcelott S, Hung OR, Law JA, MacQuarrie K, McKeen D, George RB, Ngan J. The McGrath(R) Series 5 videolaryngoscope vs the Macintosh laryngoscope: a randomised, controlled trial in patients with a simulated difficult airway. Anaesthesia. 2013 Feb;68(2):142-7. doi: 10.1111/anae.12075. Epub 2012 Nov 5.
Results Reference
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A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients

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