Effect of Mentoring on Endotracheal Tube Exchange Using a New Device

NCT ID: NCT02763189

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-01-31

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.

Conditions

Effects of Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

Control group will study the learning material independently. 'Self-study'.

Group Type: ACTIVE_COMPARATOR

Self-study

Intervention Type: OTHER

All subjects will receive self-study

Mentored

Mentored group will study the learning materials and then receive expert mentoring

Group Type: EXPERIMENTAL

Expert mentoring

Intervention Type: OTHER

Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.

Self-study

Intervention Type: OTHER

All subjects will receive self-study

Interventions

Expert mentoring

Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.

Intervention Type: OTHER

Self-study

All subjects will receive self-study

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Olympio, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest School of Medicine, Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 3963460 (View on PubMed)

Olympio MA, Reinke B, Abramovich A.

Reference Type: BACKGROUND

Related Links

http://www.apsf.org/newsletters/html/2006/fall/02training.htm

APSF Newsletter Article by Dr. Olympio on Technology Training

http://www.wakeforestinnovations.com/technology-for-license/endotracheal-tube-exchanger/

Product description of the novel tube exchanger used in this study.

Other Identifiers

IRB00037896

Identifier Type: -

Identifier Source: org_study_id