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Clinical Trials/NCT03733158
NCT03733158
Completed
Not Applicable

Comparison of the New Flexible Tip Bougie Catheter and Standard Bougie Stylet for Tracheal Intubation by Anesthesiologists in Different Difficult Airway Scenarios: a Randomized Crossover Trial

Lazarski University1 site in 1 country32 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergency Medicine
Sponsor
Lazarski University
Enrollment
32
Locations
1
Primary Endpoint
time to intubation
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
May 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Lazarski University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • physicians
  • give voluntary consent to participate in the study
  • none experience in videolaryngoscopy
  • less than 1 year experience in medicine

Exclusion Criteria

  • not meet the above criteria
  • wrist or low back diseases

Outcomes

Primary Outcomes

time to intubation

Time Frame: 1 day

time from pick up device to the final placement tube in trachea

Secondary Outcomes

  • Ease of use(1 day)
  • Number of optimalization maneuvers(1 day)
  • success of intubation(1 day)
  • Dental compression(1 day)

Study Sites (1)

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