Effect of Mentoring on Endotracheal Tube Exchange Using a New Device (FACETTE2)

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

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.

Study Overview

• Status: Terminated
• Conditions: Effects of Training
• Intervention / Treatment: Other: Self-study; Other: Expert mentoring

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine, Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Control group will study the learning material independently. 'Self-study'.	Other: Self-study; All subjects will receive self-study
Experimental: Mentored; Mentored group will study the learning materials and then receive expert mentoring	Other: Self-study; All subjects will receive self-study; Other: Expert mentoring; Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Michael A Olympio, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.
• Olympio MA, Reinke B, Abramovich A.

Helpful Links

• APSF Newsletter Article by Dr. Olympio on Technology Training
• Product description of the novel tube exchanger used in this study.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Training; Mentoring; Endotracheal Tube Exchange
• Other Study ID Numbers: IRB00037896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Apnea times will be shared at the conclusion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No