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Clinical Trials/NCT04701762
NCT04701762
Completed
Not Applicable

Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial

The Cleveland Clinic1 site in 1 country12,701 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intubation
Sponsor
The Cleveland Clinic
Enrollment
12701
Locations
1
Primary Endpoint
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 23, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.)

Study Sites (1)

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