HealthyNCT00690144
High-fidelity Simulation in Health Care Education
A study testing High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway). in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether the use of high-fidelity simulation in health care education is an effective training and evaluation model. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2007to Jun 2011
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthcare trainees, including medical students, nursing students, residents, nursing staff and emergency medical technicians.
Who cannot join
- any trainees unwilling to receive simulation-based training
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chih-Wei Yang, M.D., 886-2-2312-3456 ext. 1426, cwyang100@ntu.edu.tw
About this study
Official title: Prospective Study Focusing on Impact of High-fidelity Simulation in Health Care Education
The purpose of this study is to determine whether the use of high-fidelity simulation in health care education is an effective training and evaluation model.
Read the detailed description
High-fidelity simulation has many advantages in medical education. Simulation-based critical care training is especially valuable due to error-prone work settings and the high cost of patient adverse events. This study was conducted to assess the effectiveness of implementing the high-fidelity simulation in critical care training, and the feasibility of high-fidelity simulation as an evaluation tool.
- Conditions
- Healthy
- Being tested
- High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).
- Keywords
- simulation, medical education, performance of clinical reasoning and skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).Device
Critical care training using high-fidelity simulation. The case scenarios were simulated by a high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).
| Study group | Role | What they receive |
|---|---|---|
| simulation group | Experimental | the trainees in the simulation group receive simulation-based training Receives: Device: High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway). |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of clinical reasoning and skills in simulated settings
Measured: before and after the simulation-based training
Secondary outcomes (1)
clinical performance of reasoning and skills
Measured: before and after the simulation-based training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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.
- More trials run by National Taiwan University HospitalThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Matthew Huei-Ming Ma, MD, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690144
- Sponsor's protocol ID
- 200803078R
- Status last verified
- Jun 2010
- First submitted
- 28 May 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Focusing on Impact of High-fidelity Simulation in Health Care Education
- ClinicalTrials.gov ID
- NCT00690144
- Acronym / sponsor ID
- 200803078R
- Conditions
- Healthy
- Keywords
- simulation, medical education, performance of clinical reasoning and skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 4 Jun 2008 (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 purpose of this study is to determine whether the use of high-fidelity simulation in health care education is an effective training and evaluation model.
Detailed description
High-fidelity simulation has many advantages in medical education. Simulation-based critical care training is especially valuable due to error-prone work settings and the high cost of patient adverse events. This study was conducted to assess the effectiveness of implementing the high-fidelity simulation in critical care training, and the feasibility of high-fidelity simulation as an evaluation tool.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| simulation group | Experimental | Device: High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).the trainees in the simulation group receive simulation-based training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthcare trainees, including medical students, nursing students, residents, nursing staff and emergency medical technicians.
Key exclusion criteria (1 listed)
- any trainees unwilling to receive simulation-based training
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 |
|---|---|---|
| High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).Critical care training using high-fidelity simulation. The case scenarios were simulated by a high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway). | Device | simulation group |
Primary outcome
performance of clinical reasoning and skills in simulated settings
Time frame: before and after the simulation-based training
1 secondary outcome
clinical performance of reasoning and skills
Time frame: before and after the simulation-based training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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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.
Matthew Huei-Ming Ma, MD, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway). in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 29 Jun 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Wei Yang, M.D. (886-2-2312-3456 ext. 1426, cwyang100@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of clinical reasoning and skills in simulated settings (time frame: before and after the simulation-based 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 29 Jun 2010.