A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients

NCT ID: NCT03657927

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-08
• Study Completion Date: 2018-10-30

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.

Conditions

Difficult Intubation; Morbid Obesity; Videolaryngoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

C-MAC Videolaryngoscope

Morbidly obese patients intubated with C-MAC Videolaryngoscope

Group Type: ACTIVE_COMPARATOR

C-MAC videolaryngoscope

Intervention Type: DEVICE

An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

McGrath MAC videolaryngoscope

Intervention Type: DEVICE

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

McGrath MAC Videolaryngoscope

Morbidly obese patients intubated with McGrath MAC Videolaryngoscope

Group Type: ACTIVE_COMPARATOR

C-MAC videolaryngoscope

Intervention Type: DEVICE

An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

McGrath MAC videolaryngoscope

Intervention Type: DEVICE

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

Interventions

C-MAC videolaryngoscope

An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

Intervention Type: DEVICE

McGrath MAC videolaryngoscope

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Sedat AKBAS

Asst. Prof. Dr. Sedat Akbas

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sedat Akbas

Role: STUDY_DIRECTOR

Inonu University Medical Faculty

Locations

Sedat AKBAS

Malatya, Türkiye-Türkçe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 24643921 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23121470 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

sedatakbas3

Identifier Type: -

Identifier Source: org_study_id