Not provided
Not provided
Not provided
Not provided
The device did not work well enough in its current form to continue the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Control group will study the learning material independently. 'Self-study'. |
|
| Mentored | Experimental | Mentored group will study the learning materials and then receive expert mentoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expert mentoring | Other | Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Performance Score | 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. | immediately after the procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael A Olympio, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine, Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3963460 | Background | 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. | |
| Background | Olympio MA, Reinke B, Abramovich A. |
| Label | URL |
|---|---|
| APSF Newsletter Article by Dr. Olympio on Technology Training | View source |
Not provided
Apnea times will be shared at the conclusion of the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | seconds | immediately after the procedure |
|
4 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control group will study the learning material independently. 'Self-study'. Self-study: All subjects will receive self-study |
Not provided
Not provided
Early termination leading to small numbers of subjects analyzed. Technical problems with the device used in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael A. Olympio | Wake Forest School of Medicine | 3369182132 | molympio@wakehealth.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Self-study | Other | All subjects will receive self-study |
|
| Product description of the novel tube exchanger used in this study. | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Performance Score | 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. | Posted | Mean | Full Range | units on a scale | immediately after the procedure |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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 | 0 | 4 | 0 | 4 |
Not provided
Not provided
Not provided