Cardiac ArrestSIMMAX2NCT03253770
Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.
A study testing SIMMAX2 in people with Cardiac Arrest, run by Claude Bernard University at 1 site in France.
Trial summary
Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- SIMMAX2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2017to 16 Aug 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 1 to 5 (out of 5)
- to be familiar with our simulation centre (at least passed once as a resident)
Who cannot join
- no experience in simulation training
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid.
The present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.
Read the detailed description
" Errare humanum est ", to err is human. This Latin saying attributed to Seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. Improvement might arise from the use of cognitive aids.
In a first study (MAX, accepted for publication BJA) the investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), designed to be used in the hand of the leader managing the crises. Technical and non technical skills were improved in 4 out of 5 scenarios. Cardiac arrest (ventricular fibrillation) clearly happened to be a different situation compared to other crises, and no improvement could be measured with our cognitive aid.
The present study exclusively deals with the management of cardiac arrest (man in recovery ward, pregnant woman in the delivery room) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.
- Conditions
- Cardiac Arrest
- Being tested
- SIMMAX2
- Keywords
- Cognitive Aid
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMMAX2Device
Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
| Study group | Role | What they receive |
|---|---|---|
| Digital Cognitive Aid | Experimental | The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management. Receives: Device: SIMMAX2 |
| No digital aid | Experimental | No cognitive aid in the hand of the leader during crises management. Intervention : no cognitive aid in the hand of the leader during crises management. Receives: Device: SIMMAX2 |
| Paper Cognitive Aid | Experimental | The paper cognitive aid is the document officially recommended to be used in case of crises by the French Society of Anaesthesia and Intensive Care.
Intervention : paper cognitive aid in the hand of the leader during crises management. Receives: Device: SIMMAX2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Performance as compared to a Reference Task List
Number of tasks successfully performed, rated on remote video review
Measured: [ Time Frame: Time 0-30 min ]
Secondary outcomes (1)
Non technical skills performance
As measured by the Ottawa score, rated on remote video review
Measured: [ Time Frame: Time 0-30 min ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 May 2017
- Primary completion1 Aug 2017
- Study completion16 Aug 2017
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CEJKA Jean-Christophe, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253770
- Sponsor's protocol ID
- SIMMAX2
- Acronym
- SIMMAX2
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.
- ClinicalTrials.gov ID
- NCT03253770
- Acronym / sponsor ID
- SIMMAX2 / SIMMAX2
- Conditions
- Cardiac Arrest
- Keywords
- Cognitive Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- 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.
Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX, accepted for publication BJA) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid.
The present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.
Detailed description
" Errare humanum est ", to err is human. This Latin saying attributed to Seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. Improvement might arise from the use of cognitive aids.
In a first study (MAX, accepted for publication BJA) the investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), designed to be used in the hand of the leader managing the crises. Technical and non technical skills were improved in 4 out of 5 scenarios. Cardiac arrest (ventricular fibrillation) clearly happened to be a different situation compared to other crises, and no improvement could be measured with our cognitive aid.
The present study exclusively deals with the management of cardiac arrest (man in recovery ward, pregnant woman in the delivery room) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Digital Cognitive Aid | Experimental | Device: SIMMAX2The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management. |
| No digital aid | Experimental | Device: SIMMAX2No cognitive aid in the hand of the leader during crises management. Intervention : no cognitive aid in the hand of the leader during crises management. |
| Paper Cognitive Aid | Experimental | Device: SIMMAX2The paper cognitive aid is the document officially recommended to be used in case of crises by the French Society of Anaesthesia and Intensive Care. Intervention : paper cognitive aid in the hand of the leader during crises management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 1 to 5 (out of 5)
- to be familiar with our simulation centre (at least passed once as a resident)
Key exclusion criteria (1 listed)
- no experience in simulation 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 |
|---|---|---|
| SIMMAX2Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room. | Device | Digital Cognitive Aid, No digital aid, Paper Cognitive Aid |
Primary outcome
Technical Performance as compared to a Reference Task List
Time frame: [ Time Frame: Time 0-30 min ]
Number of tasks successfully performed, rated on remote video review
1 secondary outcome
Non technical skills performance
Time frame: [ Time Frame: Time 0-30 min ]
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 22 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Arrest
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
RecruitingObservational study
Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Cardiac Arrest
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruitingObservational study
Therapeutic Outcomes of In-Hospital Resuscitation of Patients Admitted to the Internal Medicine Wards
Survival to Discharge With Good Neurologic Outcome Among in Hospital Cardiac Arrest Patients
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMMAX2 in people with Cardiac Arrest, run by Claude Bernard University 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 2 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 22 Aug 2017. 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?
Technical Performance as compared to a Reference Task List (time frame: [ Time Frame: Time 0-30 min ]). 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 22 Aug 2017.