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NCT02763189 Clinical Trial

Effect of Mentoring on Endotracheal Tube Exchange Using a New Device

Effects of Training Clinical Trial

— FACETTE2  

Official title:
The Effects of Mentoring on Apnea Time While Using a Novel Fiber-optic Assisted Coaxial Endotracheal Tube Exchange Device

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02763189
Other study ID # IRB00037896
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date January 2017

Study information
Verified date August 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this pilot study is to compare the time it takes to change a breathing tube with a new device, performed by two different groups of anesthesiologists; one group will study on their own how to change the tube, while the second group will also receive expert training, before either group performs the procedure for the very first time. The Investigators predict the group who gets expert training will change the tube faster, and those investigators also need to learn how much faster, before moving to a larger study.

Description:

After informed consent is obtained, two groups of randomized anesthesiologists will receive detailed instructional materials including a brochure to introduce the new device, a videotape showing how the device is used, a detailed slide show explaining each of the steps, and a checklist of the steps to perform during the exchange (E) in simulation. The Mentored group (M) will also receive expert instruction just before the procedure, while the Control group (C) will have the same amount of time to review the steps themselves. Next, they will perform the first exchange procedure (E1) while the pair of experts observe and measure the simulated patients' apnea time. The experts will then conduct a debriefing with the M group, while the C group will debrief themselves before both groups perform the exchange a second time (E2). Both groups will then receive debriefing by the experts. The apnea times and a performance assessment will be compared between M and C to determine the effects of expert training, and will also be compared within each group from E1 to E2, to determine the effect of experience on apnea time and performance. Finally, surveys conducted after E1 and E2, and before debriefing, will determine the participants' satisfaction with the new device. Data on apnea times will be used for a statistical power analysis to determine the size of a larger group necessary to show significant differences in outcomes.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - physician airway management experts - training in the skill of fiber-optic endoscopic intubation Exclusion Criteria: - non-physicians - physicians without airway management expertise - physicians without skill in fiber-optic endoscopic intubation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Expert mentoring
Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
• Self-study
All subjects will receive self-study

Locations
Country Name City State
United States Wake Forest School of Medicine, Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hudes ET, Fisher JA, Guslitz B. Difficult endotracheal reintubations: a simple technique. Anesthesiology. 1986 Apr;64(4):515-7. — View Citation

Olympio MA, Reinke B, Abramovich A.

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea Time Apnea time was measured in seconds from the time the ventilator was disconnected from the original endotracheal tube to the time the ventilator was connected to the new endotracheal tube immediately after procedure. immediately after the procedure
Secondary Performance Score The performance score is obtained form the performance Score Sheet that includes 15 actions, 1 point is given for each completed action. The minimum score is 0, the maximum score is 15. Higher scores relate to better performance. immediately after the procedure

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