A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Measure of Intubation Success
Study Overview
Brief Summary
This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.
Detailed Description
Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:
- •mallampati classification 3
- •mallampati classification 4
- •Reduced mouth opening (<3cm)
- •reduced cervical motion
- •history of previous difficult intubation or multiple laryngoscopy attempts
Exclusion Criteria
- •Patients less than 18 years old, patients who are not fasted (>6 hrs. NPO)
- •Patients who have contraindications to the administration of neuromuscular blocking drugs
- •Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view
- •Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.
Arms & Interventions
CMAC Video laryngoscope
Subjects will have their intubation attempted first with the CMAC video laryngoscope
Intervention: CMAC video laryngoscope (Device)
Macintosh blade
Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade
Intervention: Macintosh laryngoscope (Device)
Outcomes
Primary Outcomes
Measure of Intubation Success
Time Frame: During each intubation in a 14 month period
Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure
Secondary Outcomes
- Number of Participants With Complications(1 year)
- Intubation Time(During laryngoscopy procedure)
- Number of Participants Intubated With a Rescue Device(1 year)
- Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.(1 year)
- Number of Particpants Requiring Adjuncts to Assist Intubation(1 year)
Investigators
Michael Aziz
Associate Professor Department of Anesthesiology & Perioperative Medicine
Oregon Health and Science University