McGrath Videolaryngoscopy and Direct Laryngoscopy in Morbidly Obese Patients

NCT03467048 | Completed Results DMC FDA Device

• 1 other identifier: 18-077
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Our goal is to compare conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for endotracheal intubation in very morbidly obese patients undergoing non-cardiac surgery. Specifically, we propose to test the primary hypotheses that videolaryngoscopy improves visualization of the vocal cords, defined with modified Cormack and Lehane classification, compared to direct laryngoscopy.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Classification of Glottis Visualization

  Glottis visualization is evaluated according to the modified Cormack and Lehane classification. It is a grading system from 1 to 4: 1 = full view of glottis; 2a = partial view of glottis;2b = only posterior extremity of glottis seen or only arytenoid cartilages; 3 = only epiglottis seen, none of glottis seen; 4 = neither glottis nor epiglottis seen.

  At intubation

Secondary Outcomes (2)

• Number of Intubation Failure

  intubation

• Number of Intubation Attempts Among Those With Successful Intubation

  intubation

Study Arms (2)

McGrath videolaryngoscopy

EXPERIMENTAL

Endotracheal intubation using McGrath videolaryngoscopy in an appropriate size (usually blade size 3 or 4)

Device: McGrath videolaryngoscopy

Direct laryngoscopy

ACTIVE COMPARATOR

Endotracheal intubation using direct laryngoscopy with an appropriately sized Macintosh blade (usually size 3 or 4)

Device: Direct laryngoscopy

Interventions

McGrath videolaryngoscopy DEVICE

Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance. The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.

McGrath videolaryngoscopy

Direct laryngoscopy DEVICE

Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance. The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords.

Direct laryngoscopy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery requiring oral endotracheal intubation for general anesthesia;
• Anticipated extubation in the operating room;
• American Society of Anesthesiologists (ASA) physical status 1-3;
• Age between 18 and 99 years;
• Body Mass index ≥ 40 kg/m2.

You may not qualify if:

• Refusal of participation by attending anesthesiologist;
• Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
• Indicated fiberoptic awake intubation.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Medtronic: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Ruetzler K, Rivas E, Cohen B, Mosteller L, Martin A, Keebler A, Maheshwari K, Steckner K, Wang M, Praveen C, Khanna S, Makarova N, Sessler DI, Turan A. McGrath Video Laryngoscope Versus Macintosh Direct Laryngoscopy for Intubation of Morbidly Obese Patients: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):586-593. doi: 10.1213/ANE.0000000000004747.

  PMID: 32175948 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kurt Ruetzler
• Organization: Cleveland Clinic

ruetzlk@ccf.org

216-445-8105

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 15, 2018
• Study Start: July 24, 2018
• Primary Completion: June 30, 2019
• Study Completion: May 20, 2020
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-06

Locations

US (1)