Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03839017 |
| Other study ID # |
SIMMAXMARCHERYAN2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 29, 2019 |
| Est. completion date |
February 21, 2020 |
Study information
| Verified date |
July 2020 |
| Source |
Claude Bernard University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
