Clinical trial NCT03657927: A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Morbid Obesity
Videolaryngoscopy
Keywords: Morbidly Obese
Difficult Airway Management
Videolaryngoscopy
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Time to intubation
timeFrame: From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Secondary outcomes:
measure: Heart Rate
timeFrame: From beginning of Anesthesia induction to 5th minutes of intubation
measure: Mean Arterial Pressure
timeFrame: From beginning of Anesthesia induction to 5th minutes of intubation
measure: Adverse Events
timeFrame: During the first 24 hour postoperatively
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Sedat AKBAS
state: Türkiye-Türkçe
Study officials:
affiliation: Inonu University Medical Faculty
name: Sedat Akbas
role: STUDY_DIRECTOR
References:
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.
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.