McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation

NCT05850052 | Completed Results

• 1 other identifier: McGrady Study
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With 1, 2, 3, and 4 Intubation Attempts

  From the start time of intubation to time of the end of surgery, up to 12 hours.

• Intubation Failure.

  From the start time of intubation to time of the end of surgery, up to 12 hours.

Study Arms (2)

McGrath Videolaryngoscope for rapid endotracheal intubation

EXPERIMENTAL

The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

Device: McGrath videolaryngoscope for rapid sequence endotracheal intubation

Efficacy of conventional direct laryngoscopy

OTHER

The researchers seek to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade.

Device: Conventional direct laryngoscopy using a Macintosh blade

Interventions

McGrath videolaryngoscope for rapid sequence endotracheal intubation DEVICE

Visualize a patient's airway to aid placement of tracheal tube with ease.

McGrath Videolaryngoscope for rapid endotracheal intubation

Conventional direct laryngoscopy using a Macintosh blade DEVICE

Examine a patient's airway to aid placement of tracheal tube with ease.

Efficacy of conventional 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 2-3;
• 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

Study Sites (2)

The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital,

Istanbul, Turkey (Türkiye)

Location

The University of Health Science, Konya City Hospital

Konya, Turkey (Türkiye)

Location

Results Point of Contact

• Title: YanYan Han
• Organization: Cleveland Clinic Foundation

HANY3@ccf.org

216-444-2250

Study Officials

• Kurt Ruetzler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 9, 2023
• Study Start: May 7, 2023
• Primary Completion: June 5, 2024
• Study Completion: August 5, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Locations

TU (2)