Clinical trial NCT02763189: Effect of Mentoring on Endotracheal Tube Exchange Using a New Device
Official title: The Effects of Mentoring on Apnea Time While Using a Novel Fiber-optic Assisted Coaxial Endotracheal Tube Exchange Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Effects of Training
Keywords: Mentoring
Endotracheal Tube Exchange
Training
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Apnea Time
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Performance Score
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine, Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael A Olympio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hudes ET, Fisher JA, Guslitz B. Difficult endotracheal reintubations: a simple technique. Anesthesiology. 1986 Apr;64(4):515-7. doi: 10.1097/00000542-198604000-00020. No abstract available.
citation: Olympio MA, Reinke B, Abramovich A.