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War InjuryNCT03839017

Impact on Performance of the Use of a Digital Cognitive Aid in Simulated Crisis and Stress Situations

A study testing SIMMAXMARCHERYAN2 in people with War Injury, run by CEJKA Jean-Christophe at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The previous investigators' studies (MAX, Lelaidier et al, BJA 2017, \& SIMMAXMARCHERYAN) clearly showed that the use of a digital cognitive aid in the hand of the leader significantly improves the management of anaesthesia and intensive care emergencies as well as basic combat casualty care. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
War Injury
What is being tested?
SIMMAXMARCHERYAN2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteFrance
Study dates
29 Jan 2019to 21 Feb 2020
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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Military doctors and Nurses
  • Under initial or continuous training of Combat Casualty Care 3rd level
  • Agreed to use the cognitive aid

Who cannot join

  • Doesn't agree to use the cognitive aid

Trial locations and contacts

1 site in 1 country.

France1 site
  • CESimMO

    Toulon, PACA, 83000

Other trials in France

About this study

The previous investigators' studies (MAX, Lelaidier et al, BJA 2017, \& SIMMAXMARCHERYAN) clearly showed that the use of a digital cognitive aid in the hand of the leader significantly improves the management of anaesthesia and intensive care emergencies as well as basic combat casualty care.

The present study exclusively deals with the advanced management of simulated combat casualties by military doctors and nurses using the same digital cognitive aid adapted for MARCHE RYAN algorithm.

Read the detailed description

The epidemiology of battlefield mortality highlights the need for safety and speed of care in an environment under very high stress. Indeed, it has been found that about 90% of those killed in action die before reaching the first hospital or care unit. Management algorithms such as ABCDE, SAFE MARCHE RYAN and local protocols are among the many doctrines to be applied by military health professionals when dealing with serious trauma in emergencies in different practice settings. During combat, their actions are carried out under enemy fire, in darkness, in extreme environments, for a significant number of victims and with limited means. As a result, on the battlefield, this multitude of choices and specific conditions of practice can make it difficult to apply the guidelines for the management of war-wounded in critical and stressful situations and can be a source of medical error. Health simulation is one of the main tools for training and preparation in a safe environment for unsafe situations ("never the first time on the patient"). A new decision-making and protocolization tool is available for health professionals: the MAX (Medical Assistant eXpert) cognitive aid, which has already proven its effectiveness in reducing the number of errors in the management of vital distress in anesthesia and in basic combat casualty care.

Materials and Methods:

Population studied: military doctors and nurses from the forces, both male and female, of varying ages and operational experience, planned to be deployed on External Operations (OPEX) or Short-term Mission (MCD), designated by the Val-de-Grâce School as learners for the " Survival Conditioning of the War Wounded " (MCSBG) continuing training course.

Study design (conduct): analytical, prospective, randomized, controlled, unblinded study conducted during the MCSBG training courses as part of the operational preparation of military doctors and nurses of the forces within the Center for Education and Simulation in Operational Medicine (CESimMO) in Toulon. The investigators had four pairs of learners work on one afternoon during each week-long training session. Each pair of learners completed two different scenarios of similar difficulty and complexity. Four blocks of scenarios were defined on which the pairs were able to work. The pairs were initially randomly assigned to two groups: Group 1 where the first scenario was performed with the MAX CA and Group 2 where the CA was used in the second scenario. Each group therefore performed a simulated scenario with and without MAX. The scenarios used either high-fidelity mannequins (SimMan 3G / ALS, Laerdal, Stavanger, Stavanger, Norway) or hybrid standardized patients (standardized subjects equipped with anatomical prostheses that allowed their management including technical procedures).

MAX CA Description: MAX is a digital AC, developed by J.C. CEJKA, and initially intended for the management of anesthesia and resuscitation emergencies. For the MARCHE RYAN protocol, each action was presented sequentially by the CA and had to be validated before the next one was displayed (READ and DO mode). It was possible to go back in order to review the validated actions and at the end of the procedure, the user had the possibility to make a final check of all his actions. The evaluation of the effectiveness of MAX was previously carried out at the Lyon center for teaching through health simulation (CLESS, UCBL1 - Claude Bernard University Lyon 1), but also during the training of Medicalization in hostile environments (MEDICHOS) and the continuing training in 2nd level combat rescue / casualty care (SC).

Use of the AC MAX in the study: Each participant disposed of a MAX application when dealing with war wounded in simulated situations. The presentation of the application and its handling was done on the first morning of each course, and a license for downloading and using the application was granted to each participant. The instructors were present to answer any questions about this CA. The anonymity of the study participants was ensured and their volunteering as well as the authorization to take pictures and use the videos collected at the beginning of each course.

Participants were requested to absolutely use the application for one of the two scenarios (randomized choice). The fact of being able to use MAX was communicated to them each time during the scenario briefing. More precisely, the one running the MARCHE RYAN algorithm had to use the MAX AC for a complete sequence, from the beginning of the scenario and follow MAX's prompts until the end of the protocol. The participants decided who in the pair will use MAX, however this person had to use both MAX+ and MAX- scenarios according to the MARCHE RYAN protocol. One of the instructors/facilitators who followed this process was to remind them of this requirement during the care of war wounded when necessary, and to impose the use of CA, if applicable.

Randomization by block allocation was performed using open source software R (randomizr library, R Foundation for Statistical Computing, Vienna, Austria, version 3.4.1), to have a homogeneous distribution of participants in Group 1 (MAX first) and Group 2 (MAX second), according to four blocks (1 block per scenario passage). The types of scenarios, the locations where the training took place and the distribution of trainers were the same for all MCSBG courses included in the study. The designation of the pairs was made on the first day of each course by the trainers in title of the CESimMO of Toulon, from the list of trainees participating.

The calculation of the number of subjects required was carried out a priori on the basis of data from the work of R. Lelaidier and M. Truchot studying the effect of MAX CA on technical and non-technical performance. In this work, the scenarios being of similar difficulty, investigators do not expect any significant effect from this factor, so the differences in means will be influenced by the use of MAX. The size of the expected effect was calculated from a mean difference of 13 points, and a standard deviation of sd=11, with n=8 groups (4 scenario blocks with or without MAX), which equates to a MAX CA effect size of 0.4 between the eight groups. The recruitment of 32 pairs will allow investigators to have a power of 0.88 with a first species risk of 0.05. In other words, a population of 32 pairs will allow investigators to show a minimum effect size of f=0.35, with a power of 0.8 and a first species risk of 0.05. There was no interim analysis planned for this study.

Data collection and analysis:

All performances were filmed (using GoPro Hero 4 cameras, San Mateo, California, USA) and anonymized. Each video recording of the MAX+ and MAX- scenarios was remotely rated by two independent evaluators (NP and PR), using the technical and non-technical performance rating grids. The scales used have already been published in international journals. If a difference of more than one point out of 10 was found between the two ratings, a third assessor (AP) would act as mediator.

A questionnaire (quiz) was also distributed to participants at the end of each course to find out how they felt about the influence of the use of the AC MAX on their performance.

Conditions
War Injury
Being tested
SIMMAXMARCHERYAN2
Keywords
Forward medicalization, Cognitive aid, Crisis situation, High-fidelity simulation, Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIMMAXMARCHERYAN2Device

    Digital cognitive aid during the management of simulated war wounded.

Study groups in NCT03839017
Study groupRoleWhat they receive
Digital cognitive aidExperimentalThe leader uses a digital cognitive aid designed as a smartphone app during advanced combat casualty care. Intervention: Device: SIMMAXMARCHERYAN2 Digital cognitive aid during the management of simulated war wounded.
Receives: Device: SIMMAXMARCHERYAN2
Without digital cognitive aidExperimentalThe leader practices advanced combat casualty care without the digital cognitive aid designed as a smartphone app. Intervention: Device: SIMMAXMARCHERYAN2 Without digital cognitive aid during the management of simulated war wounded.
Receives: Device: SIMMAXMARCHERYAN2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical Performance: percentage of actions and steps in the MARCHE RYAN protocol performed by each subject with or without the CA MAX

    As compared to a Reference Task List including between 11 and 16 critical actions to be performed. This grid was used to rate technical performance in each scenario. Each action was recorded: 0 (action not performed), 1 (action performed at the wrong time, with the wrong dosage or inaccurately) or 2 (action performed correctly and at the right time). The individual scores were summed and transformed into a percentage of the maximum achievable score.

    Statistical analysis and calculation of the number of pairs required:

    The analysis of the effect of the use of MAX CA on learners' technical performance will be carried out using a 3-factor repeated-measure ANOVA: the use of MAX, the scenario, and whether the scenario is played first or second. A post-hoc analysis by the Bonferroni test will be carried out to compare the groups.

    Measured: Time 0-30 minutes

Secondary outcomes (1)
  1. Non technical skills performance measured using the TEAM scale, MAX+ vs MAX-

    As measured by the TEAM scale score. Each of the 11 skills was rated between 0 and 4, and the overall performance between 1 and 10, for a maximum total of 54 points. Non-technical performance could therefore vary between 1 and 54.

    Measured: Time 0-30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start29 Jan 2019
  3. Primary completion21 Nov 2019
  4. Study completion21 Feb 2020

Resources

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
Model description
With or without the cognitive aid
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03839017
Sponsor's protocol ID
SIMMAXMARCHERYAN2
Status last verified
Jul 2020
First submitted
7 Feb 2019
Last updated
16 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Paraschiv AP, Cejka JC, Lilot M, Aigle L, Lehot JJ, Balanca B. Impact of a Digital Cognitive Aid on the Performance of Military Healthcare Teams During Critical Care Management in a Warfront Injury Situation: A Simulation Randomized Controlled Study. Simul Healthc. 2022 Jun 1;17(3):163-169. doi: 10.1097/SIH.0000000000000623. Epub 2021 Dec 15.

    PubMed 34934026

Questions about this trial

What is this clinical trial studying?

A study testing SIMMAXMARCHERYAN2 in people with War Injury, 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 3 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 16 Jul 2020. 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: percentage of actions and steps in the MARCHE RYAN protocol performed by each subject with or without the CA MAX (time frame: Time 0-30 minutes). 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 NCT03839017, 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 16 Jul 2020.

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