Cognitive AidsSIMMAXNCT02678819
Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.
A study testing Digital cognitive aid in people with Cognitive Aids, run by CEJKA Jean-Christophe at 1 site in France.
Trial summary
The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cognitive Aids
- What is being tested?
- Digital cognitive aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Apr 2016
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 2 to 5 (out of 5)
Who cannot join
- All other residents, including Resident Physicians training in Anesthesia/Intensive care, year 1 (out of 5)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Lyonnais d'Enseignement par la Simulation en Santé
Lyon, 69008
About this study
The purpose of this study is to determine whether a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.
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.
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), easy to use with a manual validation of every simple step. Investigators seek to compare the technical and non technical management of these crises with and without this wearable cognitive aid.
- Conditions
- Cognitive Aids
- Being tested
- Digital cognitive aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cognitive aidDevice
Digital cognitive aid during anesthesia and intensive care crises.
| Study group | Role | What they receive |
|---|---|---|
| Digital Aid | Experimental | The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid during anesthesia and intensive care crises management. Receives: Device: Digital cognitive aid |
| No digital aid | No intervention | Anesthesia and intensive care crises managed without any cognitive aid. |
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 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 posted10 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive AidsStudies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEJKA Jean-Christophe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CEJKA Jean-Christophe, Claude Bernard University
- Investigators
- Jean-Christophe CEJKA, MD PhD mEng, Principal investigator, Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678819
- Sponsor's protocol ID
- SIMMAX UCBL
- Acronym
- SIMMAX
- Status last verified
- Jul 2016
- First submitted
- 4 Feb 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lelaidier R, Balanca B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmele T, Cejka JC. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):1015-1021. doi: 10.1093/bja/aex256.
PubMed 29028930
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Wearable Digital Cognitive Aid in Simulated Anesthesia and Intensive Care Crises.
- ClinicalTrials.gov ID
- NCT02678819
- Acronym / sponsor ID
- SIMMAX / SIMMAX UCBL
- Conditions
- Cognitive Aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CEJKA Jean-ChristopheUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Feb 2016 (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 a wearable digital cognitive aid has an effect in the management of simulated crises in anesthesia or intensive care.
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.
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), easy to use with a manual validation of every simple step. Investigators seek to compare the technical and non technical management of these crises with and without this wearable cognitive aid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Aid | Experimental | Device: Digital cognitive aidThe digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid during anesthesia and intensive care crises management. |
| No digital aid | No intervention | –Anesthesia and intensive care crises managed without any cognitive aid. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident Physicians training in Anesthesia/Intensive care (same specialization in France), year 2 to 5 (out of 5)
Key exclusion criteria (1 listed)
- All other residents, including Resident Physicians training in Anesthesia/Intensive care, year 1 (out of 5)
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 |
|---|---|---|
| Digital cognitive aidDigital cognitive aid during anesthesia and intensive care crises. | Device | Digital Aid |
Primary outcome
Technical Performance as compared to a Reference Task List
Time frame: Time 0-30 min
Number of tasks successfully performed, rated on remote video review
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 26 Jul 2016.
- Derived from this study: PubMed 29028930Lelaidier R, Balanca B, Boet S, Faure A, Lilot M, Lecomte F, Lehot JJ, Rimmele T, Cejka JC. Use of a hand-held digital cognitive aid in simulated crises: the MAX randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):1015-1021. doi: 10.1093/bja/aex256.
- Individual participant dataSharing planned: No
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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.
Jean-Christophe CEJKA, MD PhD mEng principal investigator
Centre Lyonnais d'Enseignement par la Simulation en Santé, LYON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital cognitive aid in people with Cognitive Aids, run by CEJKA Jean-Christophe 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 26 Jul 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 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 0-30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678819, which also lists 1 linked publication.
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 26 Jul 2016.