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

A Comparison of McGrath® MAC Versus C-MAC® Videolaryngoscopes in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized, Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; Difficult Intubation; Videolaryngoscopy
• Intervention / Treatment: Device: C-MAC videolaryngoscope; Device: McGrath MAC videolaryngoscope

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Türkiye-Türkçe
    • Malatya, Türkiye-Türkçe, Turkey, 44090
      • Sedat Akbas

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart Rate	From beginning of Anesthesia induction to 5th minutes of intubation
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	During the first 24 hour postoperatively
Mean Arterial Pressure	Mean Arterial Pressure	From beginning of Anesthesia induction to 5th minutes of intubation

Collaborators and Investigators

• Sponsor: Inonu University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2018
• Primary Completion (Actual): October 20, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; Morbidly Obese; Difficult Airway Management
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: sedatakbas3

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
• product manufactured in and exported from the U.S.: No