McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850052
• Other study ID #: McGrady Study
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2023
• Est. completion date: June 2026

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: Fabio Rodriguez, MD
• Email: rodrigf3[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Conventional direct laryngoscopy using a Macintosh blade
Examine a patient's airway to aid placement of tracheal tube with ease.

Device:
• McGrath videolaryngoscope for rapid sequence endotracheal intubation
Visualize a patient's airway to aid placement of tracheal tube with ease.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization of the vocal cords	Our primary outcomes is visualization of the vocal cords, defined using the modified Cormack and Lehane classification	Within 1 hours anesthesia induction.
Secondary	Number of intubation attempts, and failures.	Secondary outcomes are number of intubation attempts and the number of intubation failures.	Within 1 hour of anesthesia induction.