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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657927
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sedat AKBAS, Inonu University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Difficult Intubation Morbid Obesity Videolaryngoscopy Device: C-MAC videolaryngoscope Device: McGrath MAC videolaryngoscope Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Comparison of McGrath® MAC Versus C-MAC® Videolaryngoscopes in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized, Controlled Clinical Trial
Actual Study Start Date : September 8, 2018
Actual Primary Completion Date : October 20, 2018
Actual Study Completion Date : October 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: C-MAC Videolaryngoscope
Morbidly obese patients intubated with C-MAC Videolaryngoscope
 Device: C-MAC videolaryngoscope
An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

Device: McGrath MAC videolaryngoscope
An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.
Active Comparator: McGrath MAC Videolaryngoscope
Morbidly obese patients intubated with McGrath MAC Videolaryngoscope
 Device: C-MAC videolaryngoscope
An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

Device: McGrath MAC videolaryngoscope
An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.


Outcome Measures
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Primary Outcome Measures :
  1. Time to intubation [ Time Frame: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes ]
    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 :
  1. Heart Rate [ Time Frame: From beginning of Anesthesia induction to 5th minutes of intubation ]
    Heart Rate

  2. Mean Arterial Pressure [ Time Frame: From beginning of Anesthesia induction to 5th minutes of intubation ]
    Mean Arterial Pressure

  3. Adverse Events [ Time Frame: During the first 24 hour postoperatively ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657927


Locations
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Turkey
Sedat AKBAS
Malatya, Türkiye-Türkçe, Turkey, 44090
Sponsors and Collaborators
Inonu University
Investigators
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Study Director: Sedat Akbas Inonu University Medical Faculty
  Study Documents (Full-Text)

Documents provided by Sedat AKBAS, Inonu University:
Study Protocol and Statistical Analysis Plan  [PDF] June 27, 2018

More Information
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Publications:

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Responsible Party: Sedat AKBAS, Asst. Prof. Dr. Sedat Akbas, Inonu University
ClinicalTrials.gov Identifier: NCT03657927    
Other Study ID Numbers: sedatakbas3
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sedat AKBAS, Inonu University:
Morbidly Obese
Difficult Airway Management
Videolaryngoscopy
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight