Cardiac ArrestSIMCARENCT02483546
High Fidelity Simulation vs Standard Teaching Training of Cardiac Resuscitation
A study testing Laerdal®, huma patient based training and traditionally teaching in people with Cardiac Arrest, run by University of Monastir at 1 site in Tunisia.
Trial summary
High fidelity Simulation has spread from anesthesiology to other disciplines such as internal medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in medical education has increased exponentially. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Laerdal®, huma patient based training and traditionally teaching
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2014to Sep 2015
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medecine students
Who cannot join
- Non Medecine students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Fidelity Simulation In Medecine Education
High fidelity Simulation has spread from anesthesiology to other disciplines such as internal medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in medical education has increased exponentially. The term ''simulation'' spans a wide variety of formats, from the low-tech actor portraying a standardized patient to high-fidelity mannequin-based human patient simulation (HPS). HPS is able of both simulating realistic patient encounters and giving real-time, physiologically accurate feedback. Studies thus far show that use of simulation in training medical students and residents is helpful in strengthening students' knowledge and in evaluating their performance. Students appreciate simulation-based education as ''an opportunity to learn new skills in a safe environment .
Read the detailed description
This was a randomized, controlled trial of a simulation- based educational intervention designed to increase medicine student's clinical skills in cardiac arrest procedures .The investigators included 181 fifth-year medical students rotating in the emergency department of Fattouma Bourguiba University hospital of Monastir (Tunisia) during the period from January 2013 to January 2014.Students were randomized into two groups using a random number generator to an intervention group (simulatortrained, n = 99) or a control group (traditionally teaching, n =82).
The investigators conducted a prospective, randomized, non-blinded study to determine whether simulation based training is superior to traditional teaching in the assessment and management of simulated patients presenting with myocardial infarction (MI) complicated by ventricular fibrillation.
- Conditions
- Cardiac Arrest
- Being tested
- Laerdal®, huma patient based training, traditionally teaching
- Keywords
- Medical education, simulation, ACLS
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laerdal®Device
simulation- based educational intervention
huma patient based trainingBehavioural
Students randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case.
traditionally teachingBehavioural
Control group students received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups.
| Study group | Role | What they receive |
|---|---|---|
| huma patient based training | Experimental | Students randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case. Receives: Device: Laerdal®; Behavioral: huma patient based training |
| traditionally teaching | Active comparator | students received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups. Receives: Behavioral: traditionally teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
better acquisition of cognitive skills for students
Pretest using 20 multiple choice questions after randomization. A second round of the same testing was then conducted for both groups just after the course (posttest). The test score range from 0 to 20 (maximum). The difference between the rating of the post-test and pre-test identifies the delta score of the student.
Measured: just after randomisation (one day)
Secondary outcomes (1)
Satisfaction 5 point likert scale
Students rated their satisfaction level with a 5 point likert scale framed as attitude toward simulation compared with control group: dissatisfied (1 point), fairly satisfied (2 points), neither satisfied (3points), satisfied (4 points), and very satisfied (5 points).
Measured: just after randomisation (one day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Hamdi Boubaker, MD, Principal investigator, Emergency Department , university Hospital of Monastir 5000 TUNISIAMohamed habib GRISSA, MD, Principal investigator, Emergency Department , university Hospital of Monastir 5000 TUNISIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483546
- Sponsor's protocol ID
- 12345
- Acronym
- SIMCARE
- Status last verified
- Jun 2016
- First submitted
- 20 Feb 2015
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fidelity Simulation In Medecine Education
- ClinicalTrials.gov ID
- NCT02483546
- Acronym / sponsor ID
- SIMCARE / 12345
- Conditions
- Cardiac Arrest
- Keywords
- Medical education, simulation, ACLS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Jun 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.
High fidelity Simulation has spread from anesthesiology to other disciplines such as internal medicine, pediatrics, and emergency medicine . Over the past decade, the use of simulation in medical education has increased exponentially. The term ''simulation'' spans a wide variety of formats, from the low-tech actor portraying a standardized patient to high-fidelity mannequin-based human patient simulation (HPS). HPS is able of both simulating realistic patient encounters and giving real-time, physiologically accurate feedback. Studies thus far show that use of simulation in training medical students and residents is helpful in strengthening students' knowledge and in evaluating their performance. Students appreciate simulation-based education as ''an opportunity to learn new skills in a safe environment .
Detailed description
This was a randomized, controlled trial of a simulation- based educational intervention designed to increase medicine student's clinical skills in cardiac arrest procedures .The investigators included 181 fifth-year medical students rotating in the emergency department of Fattouma Bourguiba University hospital of Monastir (Tunisia) during the period from January 2013 to January 2014.Students were randomized into two groups using a random number generator to an intervention group (simulatortrained, n = 99) or a control group (traditionally teaching, n =82).
The investigators conducted a prospective, randomized, non-blinded study to determine whether simulation based training is superior to traditional teaching in the assessment and management of simulated patients presenting with myocardial infarction (MI) complicated by ventricular fibrillation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| huma patient based training | Experimental | Device: Laerdal®, Behavioral: huma patient based trainingStudents randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case. |
| traditionally teaching | Active comparator | Behavioral: traditionally teachingstudents received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medecine students
Key exclusion criteria (1 listed)
- Non Medecine students
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 |
|---|---|---|
| Laerdal®simulation- based educational intervention | Device | huma patient based training |
| huma patient based trainingStudents randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case. | Behavioural | huma patient based training |
| traditionally teachingControl group students received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups. | Behavioural | traditionally teaching |
Primary outcome
better acquisition of cognitive skills for students
Time frame: just after randomisation (one day)
Pretest using 20 multiple choice questions after randomization. A second round of the same testing was then conducted for both groups just after the course (posttest). The test score range from 0 to 20 (maximum). The difference between the rating of the post-test and pre-test identifies the delta score of the student.
1 secondary outcome
Satisfaction 5 point likert scale
Time frame: just after randomisation (one day)
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 20 Jun 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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.
Hamdi Boubaker, MD principal investigator
Emergency Department , university Hospital of Monastir 5000 TUNISIA
Mohamed habib GRISSA, MD principal investigator
Emergency Department , university Hospital of Monastir 5000 TUNISIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laerdal®, huma patient based training and traditionally teaching in people with Cardiac Arrest, run by University of Monastir at 1 site in Tunisia.
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 20 Jun 2016. 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 Tunisia. 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?
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?
better acquisition of cognitive skills for students (time frame: just after randomisation (one day)). 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 20 Jun 2016.