Effects of TrainingFACETTE2NCT02763189
Effect of Mentoring on Endotracheal Tube Exchange Using a New Device
A study testing Expert mentoring and Self-study in people with Effects of Training, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Effects of Training
- What is being tested?
- Expert mentoring and Self-study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- physician airway management experts
- training in the skill of fiber-optic endoscopic intubation
Who cannot join
- non-physicians
- physicians without airway management expertise
- physicians without skill in fiber-optic endoscopic intubation
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine, Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effects of Mentoring on Apnea Time While Using a Novel Fiber-optic Assisted Coaxial Endotracheal Tube Exchange Device
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.
Read the 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.
- Conditions
- Effects of Training
- Being tested
- Expert mentoring, Self-study
- Keywords
- Mentoring, Endotracheal Tube Exchange, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert mentoringOther
Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
Self-studyOther
All subjects will receive self-study
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control group will study the learning material independently. 'Self-study'. Receives: Other: Self-study |
| Mentored | Experimental | Mentored group will study the learning materials and then receive expert mentoring Receives: Other: Expert mentoring; Other: Self-study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the procedure
Secondary outcomes (1)
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.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: The device did not work well enough in its current form to continue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effects of TrainingStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Olympio, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763189
- Sponsor's protocol ID
- IRB00037896
- Acronym
- FACETTE2
- Status last verified
- Aug 2018
- First submitted
- 3 May 2016
- Last updated
- 11 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Apnea times will be shared at the conclusion of the study
Publications
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.
PubMed 3963460Olympio MA, Reinke B, Abramovich A.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mentoring on Apnea Time While Using a Novel Fiber-optic Assisted Coaxial Endotracheal Tube Exchange Device
- ClinicalTrials.gov ID
- NCT02763189
- Acronym / sponsor ID
- FACETTE2 / IRB00037896
- Conditions
- Effects of Training
- Keywords
- Mentoring, Endotracheal Tube Exchange, Training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The device did not work well enough in its current form to continue the study.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Self-studyControl group will study the learning material independently. 'Self-study'. |
| Mentored | Experimental | Other: Expert mentoring, Other: Self-studyMentored group will study the learning materials and then receive expert mentoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- physician airway management experts
- training in the skill of fiber-optic endoscopic intubation
Key exclusion criteria (3 listed)
- non-physicians
- physicians without airway management expertise
- physicians without skill in fiber-optic endoscopic intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expert mentoringExperts will provide personalized instructional review on how to use the new device for changing endotracheal tubes. | Other | Mentored |
| Self-studyAll subjects will receive self-study | Other | Control, Mentored |
Primary outcome
Apnea Time
Time frame: 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.
1 secondary outcome
Performance Score
Time frame: immediately after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3963460Hudes 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.
- BackgroundOlympio MA, Reinke B, Abramovich A.
- Product description of the novel tube exchanger used in this study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Apnea times will be shared at the conclusion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Olympio, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expert mentoring and Self-study in people with Effects of Training, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Time (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763189, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.