in Hospital Cardiac ArrestSIMACRISNCT02065934
Clinical Audit of Cardio Pulmonary Resuscitation Management in Adults Patient Units of Care by in Situ Simulation
An observational study of in Hospital Cardiac Arrest and in Situ Simulation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Clinical audit of in-hospital cardiac arrest management by in situ simulation Objectives: correct latent safety threats, knowledge gap, and crisis resource management (CRM) Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation scale. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- in Hospital Cardiac Arrest, in Situ Simulation, Clinical Audit
- What is being tested?
- cardio-pulmonary resuscitation
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jun 2015
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Team members
Who may be able to join
- team members: nurses, auxiliary nurses, residents, doctors, students
Who cannot join
- non volunteers
Trial locations and contacts
1 site in 1 country.
About this study
Clinical audit of in-hospital cardiac arrest management by in situ simulation
Objectives: correct latent safety threats, knowledge gap, and crisis resource management (CRM)
Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation scale. Exploratory outcomes: non technical skills, validated stress inventory, and questionnaire on perceptions of the simulation and organisational changes needed.
- Being tested
- cardio-pulmonary resuscitation
- Keywords
- in hospital cardiac arrest, in situ simulation, clinical audit, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardio-pulmonary resuscitationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital resuscitation scale
Measured: 5 months
Secondary outcomes (3)
ANTS scale
Measured: 5 months
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
validated stress inventory
Measured: 5 months
Peritraumatic Distress Inventory (PDI)
validated stress inventory
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannick BRUNIN, Centre Hospitalier Universitaire de Besancon
- Investigators
- Yannick BRUNIN, Dr, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065934
- Sponsor's protocol ID
- EI/2013/116
- Acronym
- SIMACRIS
- Status last verified
- Jul 2015
- First submitted
- 13 Jan 2014
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit of Cardio Pulmonary Resuscitation Management in Adults Patient Units of Care by in Situ Simulation
- ClinicalTrials.gov ID
- NCT02065934
- Acronym / sponsor ID
- SIMACRIS / EI/2013/116
- Keywords
- in hospital cardiac arrest, in situ simulation, clinical audit, education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Feb 2014 (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.
Clinical audit of in-hospital cardiac arrest management by in situ simulation
Objectives: correct latent safety threats, knowledge gap, and crisis resource management (CRM)
Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation scale. Exploratory outcomes: non technical skills, validated stress inventory, and questionnaire on perceptions of the simulation and organisational changes needed.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Team members
Key inclusion criteria (1 listed)
- team members: nurses, auxiliary nurses, residents, doctors, students
Key exclusion criteria (1 listed)
- non volunteers
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 |
|---|---|---|
| cardio-pulmonary resuscitation | Other | – |
Primary outcome
In-Hospital resuscitation scale
Time frame: 5 months
3 secondary outcomes
ANTS scale
Time frame: 5 months
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
Time frame: 5 months
Peritraumatic Distress Inventory (PDI)
Time frame: 5 months
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 8 Jul 2015.
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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.
Yannick BRUNIN, Dr principal investigator
Centre Hospitalier Universitaire de Besancon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of in Hospital Cardiac Arrest and in Situ Simulation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 8 Jul 2015. 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 France. 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?
In-Hospital resuscitation scale (time frame: 5 months). 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 8 Jul 2015.