McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation

Comparison of Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Rapid Sequence Intubation: an International, Multicenter Randomized Trial

The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: McGrath videolaryngoscope for rapid sequence endotracheal intubation; Device: Conventional direct laryngoscopy using a Macintosh blade

Detailed Description

The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital,
  • Konya, Turkey
    • The University of Health Science, Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective surgery requiring oral endotracheal intubation for general anesthesia;
• Anticipated extubation in the operating room;
• American Society of Anesthesiologists (ASA) physical status 2-3;
• Age between 18 and 99 years;
• Body Mass index ≥ 40 kg/m2.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: McGrath Videolaryngoscope for rapid endotracheal intubation; The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation.	Device: McGrath videolaryngoscope for rapid sequence endotracheal intubation; Visualize a patient's airway to aid placement of tracheal tube with ease.
Other: Efficacy of conventional direct laryngoscopy; The researchers seek to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade.	Device: Conventional direct laryngoscopy using a Macintosh blade; Examine a patient's airway to aid placement of tracheal tube with ease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization of the Vocal Cords	The visualization of the vocal cords, defined using the modified Cormack and Lehane classification: Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible). Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen). Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen).	From the start time of intubation to time of the end of surgery, up to 12 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 1, 2, 3, and 4 Intubation Attempts	An intubation attempt was recorded once the endotracheal tube entered the oral cavity	From the start time of intubation to time of the end of surgery, up to 12 hours.
Intubation Failure.	Intubation was considered a failure if there was: (1) a failure to intubate after 3 attempts, (2) the need to switch intubators or intubation device, or (3) the need to stop study per anesthesiologist's discretion.	From the start time of intubation to time of the end of surgery, up to 12 hours.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kurt Ruetzler, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2023
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: McGrady Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No