Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 12,701
- Locations
- 2
- Primary Endpoint
- The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
Study Overview
Brief Summary
The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified
Detailed Description
The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia.
The investigators plan a cluster randomized multiple crossover design, where each cluster is crossed over to the other treatment in the next period. The operating suites will be divided into 2 separate clusters consisting of 11 operating suites each. Randomization will consist of randomizing cluster 1 to use either video laryngoscope or direct laryngoscope, and cluster 2 to the alternative device in one-week blocks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.
Exclusion Criteria
- •The attending anesthesiologist prefers a specific approach for a particular patient
- •Awake fiberoptic intubation is clinically indicated
- •Insertion of double-lumen tube.
Outcomes
Primary Outcomes
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
Time Frame: From the start time of intubation to time of the end of surgery up to 24 hours.
Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.
Secondary Outcomes
- Intubation Failure(From the start time of intubation to time of the end of surgery.)
- Any Dental or Airway Injury(From the start time of intubation to time of the end of surgery.)