Clinical Trial Summary
The implementation of an mechanical in-exsufflator device (MI-E) requires specific expertise
because it is a complex device that requires fine-tuning of the settings according to
different clinical situations to optimize its effectiveness. Generally, it is performed by
experienced physiotherapists in neuromuscular disease reference centers or directly at home
via medical-technical home care providers.
Treatment data is recorded by the machine at each MI-E session, which may be daily or less
frequent, depending on the patient's dependency. All of this information can be accessed by
manually downloading the data from the SD card that comes with each MI-E machine. Therefore,
the retrieval of this information systematically requires the visit of staff to the patient's
home.
To date, compliance with these devices is not regularly measured since there is no means of
telecommunication allowing remote monitoring of these therapies, whereas technological
development in the field of remote monitoring has allowed remote monitoring of patients with
sleep apnea syndrome treated with continuous positive airway pressure (CPAP) and, more
recently, of some patients with chronic respiratory insufficiency treated with invasive
ventilation (NIV). These developments are transforming on the one hand the follow-up of
patients under NIV at home by the medical and paramedical teams and on the other hand the
financial coverage by the health insurance organizations (ETAPES programs). Within the
framework of NIV therapy, we think that remote monitoring of the quality of the sessions,
i.e. measurement of peak expiratory flow, insufflated volumes, frequency and duration of the
sessions, could facilitate and improve the follow-up of these patients for the
medical-technical providers, the expert physiotherapists and the doctors of the reference
centers. It is still too early to assume the extent to which data from remote monitoring of
MI-E devices would improve patient follow-up. Nevertheless, given the increasing number of
devices installed over the past several years, it is likely that the issue of telemonitoring
will become a central issue. Thus, in this observational trial, we propose to evaluate the
feasibility of a simple system of remote monitoring of MI-E devices in non-therapy-naive
patients, with the objective of assessing the barriers and limitations of remote monitoring
in this population.
Primary aim is to evaluate the feasibility of remote monitoring of data from the MI-E device
used in the patient's home in neuromuscular diseases.
Patients will be identified by the investigators using the AGIR à dom software package
(medical-technical follow-up file). If the patient accepts, the information and no-objection
form will be sent to them electronically or by mail following this call, and at least 3 days
before their scheduled appointment.
During the patient's usual follow-up visit, if the patient does not object to participating
in the study, AGIR staff in dom will install the device. This visit will take place in the
patient's home. During this visit, a SanDisk (SD) Eye-Fi SDHC 4GB + WiFi Class4 memory card
will be inserted into the port provided, in place of the memory card already present in the
MI-E device. Then a Raspberry Pi 4 Model B will be placed in the room where the MI-E device
is normally used by the patient, and connected to a power source (accessible electrical
outlet in the room). The wifi SD card, which uses the device's power supply, will communicate
with the Raspberry Pi via the wifi network and upload the recorded data each time the MI-E
device is used.
After 90 days, a routine recovery visit will be scheduled. AGIR à dom staff will replace the
wifi SD card installed during the D0 visit with the standard SD card originally provided with
the MI-E device. The data locally on the SD Wifi card will then be downloaded for analysis
and comparison with the data being uploaded
Perspectives
Democratizing remote monitoring of cough devices would:
Potentially decrease the costs associated with data retrieval Encourage the establishment of
centers of expertise where expert practitioners could follow multiple patients (e.g., at the
provider's site).
To study the relationship between certain data from the MI-E (use, adjustment of settings,
peak expiratory flow or insufflated volume).
The development of an automated analysis system for predictive data (increase in bronchial
congestion, inefficiency of the device) to optimize the follow-up of these patients.