Effect of Mentoring on Endotracheal Tube Exchange Using a New Device

NCT02763189 | Terminated Results

• 1 other identifier: IRB00037896
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Effects of Training

Keywords

Mentoring; Endotracheal Tube Exchange; Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Performance Score

  immediately after the procedure

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Self-study

Mentored

EXPERIMENTAL

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

Other: Expert mentoring; Other: Self-study

Interventions

Expert mentoring OTHER

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

Mentored

Self-study OTHER

All subjects will receive self-study

Control; Mentored

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine, Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• 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.

  PMID: 3963460 BACKGROUND

• Olympio MA, Reinke B, Abramovich A.

  BACKGROUND

Related Links

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Technical problems with the device used in the study.

Results Point of Contact

• Title: Dr. Michael A. Olympio
• Organization: Wake Forest School of Medicine

molympio@wakehealth.edu

3369182132

Study Officials

• Michael A Olympio, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 11, 2022
• Results First Posted: March 29, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)