McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation
- Conditions
- Surgery
- Interventions
- Other: Conventional direct laryngoscopy using a Macintosh bladeDevice: McGrath videolaryngoscope for rapid sequence endotracheal intubation
- Registration Number
- NCT05850052
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Efficacy of conventional direct laryngoscopy Conventional direct laryngoscopy using a Macintosh blade The researchers seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade, McGrath Videolaryngoscope for rapid endotracheal intubation McGrath videolaryngoscope for rapid sequence endotracheal intubation The researchers will use the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
- Primary Outcome Measures
Name Time Method Visualization of the Vocal Cords 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 Outcome Measures
Name Time Method 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. An intubation attempt was recorded once the endotracheal tube entered the oral cavity
Intubation Failure. From the start time of intubation to time of the end of surgery, up to 12 hours. 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.
Trial Locations
- Locations (2)
The University of Health Science, Bakirkoy Dr. Sadi Konuk Education, and Research Hospital,
🇹🇷Istanbul, Turkey
The University of Health Science, Konya City Hospital
🇹🇷Konya, Turkey