FACETTE2: Effect of Mentoring on Endotracheal Tube Exchange Using a New Device
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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: Expert mentoring
Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
Other: Self-study
All subjects will receive self-study
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest School of Medicine, Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Michael A Olympio, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- APSF Newsletter Article by Dr. Olympio on Technology Training
- Product description of the novel tube exchanger used in this study.
Publications
- Hudes ET, Fisher JA, Guslitz B. Difficult endotracheal reintubations: a simple technique. Anesthesiology. 1986 Apr;64(4):515-7.
- Olympio MA, Reinke B, Abramovich A.
- IRB00037896
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control | Mentored |
|---|---|---|
| Arm/Group Description | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study | 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 |
| Period Title: Overall Study | ||
| STARTED | 4 | 4 |
| COMPLETED | 4 | 2 |
| NOT COMPLETED | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Control | Mentored | Total |
|---|---|---|---|
| Arm/Group Description | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study | 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 of all reporting groups |
| Overall Participants | 4 | 4 | 8 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
4
100%
|
4
100%
|
8
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
25%
|
1
25%
|
2
25%
|
| Male |
3
75%
|
3
75%
|
6
75%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
4
100%
|
4
100%
|
8
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
4
100%
|
4
100%
|
8
100%
|
Outcome Measures
| Title | Apnea Time |
|---|---|
| Description | 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. |
| Time Frame | immediately after the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Mentored |
|---|---|---|
| Arm/Group Description | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study | 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 |
| Measure Participants | 4 | 4 |
| Mean (Full Range) [seconds] |
146
|
111
|
| Title | Performance Score |
|---|---|
| Description | 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. |
| Time Frame | immediately after the procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | Mentored |
|---|---|---|
| Arm/Group Description | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study | 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 |
| Measure Participants | 4 | 4 |
| Mean (Full Range) [units on a scale] |
11.75
|
11
|
Adverse Events
| Time Frame | 4 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Control | Mentored | ||
| Arm/Group Description | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study | 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 | ||
All Cause Mortality |
||||
| Control | Mentored | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Control | Mentored | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Control | Mentored | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 0/4 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Michael A. Olympio |
|---|---|
| Organization | Wake Forest School of Medicine |
| Phone | 3369182132 |
| molympio@wakehealth.edu |
- IRB00037896