HealthyNCT02431130
Low-fidelity Simulation to Teach Anesthetists' Non-technical Skills in Rwanda
A study testing low-fidelity instructor driven simulation training in people with Healthy, run by Dalhousie University.
Trial summary
The goal of this study is to examine whether low-fidelity instructor-driven simulation can provide effective teaching of anesthetists' non-technical skills in a developing world context. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Healthy
- What is being tested?
- low-fidelity instructor driven simulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- anesthesia providers (resident or technician) that provides anesthesia for caesarean section
Who cannot join
- anesthesia providers that do not provide anesthesia for caesarean section
About this study
The goal of this study is to examine whether low-fidelity instructor-driven simulation can provide effective teaching of anesthetists' non-technical skills in a developing world context. Human factors, such as communication, planning, and team working are considered nontechnical skills which contribute greatly to patient safety in "complex hazardous systems" such as aviation, nuclear power industry, and operating rooms. Simulation began in the aviation industry to train pilots in human factors. In the past two decades simulation has been valued in medical education as it allows the learner to rehearse skills in an environment that is similar to the workplace but without the threat of harm to patients. High Fidelity simulators involve computer driven interactive mannequins that recreate an authentic environment. This has been used successfully to teach anesthetists' non-technical skills (ANTS) such as: decision making, team working, task management, and situation awareness. Anesthetists' non-technical skills are particularly important in developing countries where the shortage of supplies, equipment, and qualified personnel can lead to a perilous working environment making team work and communication vital for patient safety. The costs of high fidelity simulation are prohibitive for many developing countries. This study seeks to examine whether low fidelity instructor driven simulation can provide an effective intervention to teach anesthetists' non-technical skills in Rwanda. If found to be effective, this method of training could be applied to other developing countries to improve non-technical skills for anesthesia providers with the goal of making surgery safer.
- Conditions
- Healthy
- Being tested
- low-fidelity instructor driven simulation training
- Keywords
- Training Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-fidelity instructor driven simulation trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Low-fidelty instructor driven simulation training | Experimental | participants receive simulation training Receives: Other: low-fidelity instructor driven simulation training |
| No simulation training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in overall ANTS score after simulation training
Measured: two weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Principal investigator, Patricia Livingston, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431130
- Sponsor's protocol ID
- 2011-2596
- Status last verified
- Sep 2023
- First submitted
- 23 Apr 2015
- Last updated
- 7 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-fidelity Simulation to Teach Anesthetists' Non-technical Skills in Rwanda
- ClinicalTrials.gov ID
- NCT02431130
- Acronym / sponsor ID
- 2011-2596
- Conditions
- Healthy
- Keywords
- Training Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine whether low-fidelity instructor-driven simulation can provide effective teaching of anesthetists' non-technical skills in a developing world context. Human factors, such as communication, planning, and team working are considered nontechnical skills which contribute greatly to patient safety in "complex hazardous systems" such as aviation, nuclear power industry, and operating rooms. Simulation began in the aviation industry to train pilots in human factors. In the past two decades simulation has been valued in medical education as it allows the learner to rehearse skills in an environment that is similar to the workplace but without the threat of harm to patients. High Fidelity simulators involve computer driven interactive mannequins that recreate an authentic environment. This has been used successfully to teach anesthetists' non-technical skills (ANTS) such as: decision making, team working, task management, and situation awareness. Anesthetists' non-technical skills are particularly important in developing countries where the shortage of supplies, equipment, and qualified personnel can lead to a perilous working environment making team work and communication vital for patient safety. The costs of high fidelity simulation are prohibitive for many developing countries. This study seeks to examine whether low fidelity instructor driven simulation can provide an effective intervention to teach anesthetists' non-technical skills in Rwanda. If found to be effective, this method of training could be applied to other developing countries to improve non-technical skills for anesthesia providers with the goal of making surgery safer.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fidelty instructor driven simulation training | Experimental | Other: low-fidelity instructor driven simulation trainingparticipants receive simulation training |
| No simulation training | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- anesthesia providers (resident or technician) that provides anesthesia for caesarean section
Key exclusion criteria (1 listed)
- anesthesia providers that do not provide anesthesia for caesarean section
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 |
|---|---|---|
| low-fidelity instructor driven simulation training | Other | Low-fidelty instructor driven simulation training |
Primary outcome
Improvement in overall ANTS score after simulation training
Time frame: two weeks after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing low-fidelity instructor driven simulation training in people with Healthy, run by Dalhousie University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in overall ANTS score after simulation training (time frame: two weeks after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2023.