Effects of Training
Conditions
Keywords
Mentoring, Endotracheal Tube Exchange, Training
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.
Interventions
OTHERExpert mentoring
Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
OTHERSelf-study
All subjects will receive self-study
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control group will study the learning material independently. 'Self-study'.
Self-study: All subjects will receive self-study | 4 |
| 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 | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device failure | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Control | Mentored |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 8 participants | 4 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: immediately after the procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Apnea Time | 146 seconds |
| Mentored | Apnea Time | 111 seconds |
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.
Time frame: immediately after the procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Performance Score | 11.75 units on a scale |
| Mentored | Performance Score | 11 units on a scale |