Trial Outcomes & Findings for Effect of Mentoring on Endotracheal Tube Exchange Using a New Device (NCT NCT02763189)

Last Updated: 2022-03-11

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

immediately after the procedure

Results posted on

2022-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Control Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study	Mentored Mentored group will study the learning materials and then receive expert mentoring Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes. Self-study: All subjects will receive self-study
Overall Study STARTED	4	4
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study	Mentored Mentored group will study the learning materials and then receive expert mentoring Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes. Self-study: All subjects will receive self-study
Overall Study Device failure	0	2

Baseline Characteristics

Effect of Mentoring on Endotracheal Tube Exchange Using a New Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=4 Participants Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study	Mentored n=4 Participants Mentored group will study the learning materials and then receive expert mentoring Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes. Self-study: All subjects will receive self-study	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately after the procedure

Outcome measures

Outcome measures
Measure	Control n=4 Participants Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study	Mentored n=4 Participants Mentored group will study the learning materials and then receive expert mentoring Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes. Self-study: All subjects will receive self-study
Apnea Time	146 seconds Interval 129.0 to 164.0	111 seconds Interval 111.0 to 111.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=4 Participants Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study	Mentored n=4 Participants Mentored group will study the learning materials and then receive expert mentoring Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes. Self-study: All subjects will receive self-study
Performance Score	11.75 units on a scale Interval 11.0 to 14.0	11 units on a scale Interval 9.0 to 14.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mentored

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael A. Olympio

Wake Forest School of Medicine

Phone: 3369182132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place