Effect of Mentoring on Endotracheal Tube Exchange Using a New Device

Not Applicable

Terminated

• Conditions: Effects of Training
• Interventions: Other: Expert mentoring; Other: Self-study

• Registration Number: NCT02763189
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2016-06
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2017-02-08
• Results First Submitted QC: 2017-02-08
• Results First Posted: 2017-03-29
• Status Verified: 2018-08
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• physician airway management experts
• training in the skill of fiber-optic endoscopic intubation

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Exclusion Criteria

• non-physicians
• physicians without airway management expertise
• physicians without skill in fiber-optic endoscopic intubation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mentored	Self-study	Mentored group will study the learning materials and then receive expert mentoring
Control	Self-study	Control group will study the learning material independently. 'Self-study'.
Mentored	Expert mentoring	Mentored group will study the learning materials and then receive expert mentoring

Primary Outcome Measures

Name	Time	Method
Apnea Time	immediately after the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Performance Score	immediately after the procedure	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.

Trial Locations

Locations (1)

Wake Forest School of Medicine, Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States