McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05850052
• Collaborator: (none)
• Enrollment: 800
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 36.6
• Patients Per Site: 400
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgery	Other: Conventional direct laryngoscopy using a Macintosh blade; Device: McGrath videolaryngoscope for rapid sequence endotracheal intubation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Comparison of Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Rapid Sequence Intubation: an International, Multicenter Randomized Trial
• Anticipated Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Efficacy of conventional direct laryngoscopy The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade,	Other: Conventional direct laryngoscopy using a Macintosh blade; Examine a patient's airway to aid placement of tracheal tube with ease.
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.

Outcome Measures

Primary Outcome Measures

1. Visualization of the vocal cords [Within 1 hours anesthesia induction.]

   Our primary outcomes is visualization of the vocal cords, defined using the modified Cormack and Lehane classification

Secondary Outcome Measures

1. Number of intubation attempts, and failures. [Within 1 hour of anesthesia induction.]

   Secondary outcomes are number of intubation attempts and the number of intubation failures.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital,	Istanbul		Turkey
2	The University of Health Science, Konya City Hospital	Konya		Turkey

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT05850052
• Other Study ID Numbers: McGrady Study
• First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 9, 2023