Comparison of Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Rapid Sequence Intubation: an International, Multicenter Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Visualization of the Vocal Cords
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
Visualization of the Vocal Cords
Time Frame: From the start time of intubation to time of the end of surgery, up to 12 hours.
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).
Secondary Outcomes
- 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.)