Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723289
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2023-02-03
Brief Title:
Evaluation of the Feasibility of Remote Monitoring of Mechanical In-exsufflation Devices in Paralytic and Neuromuscular Patients Treated at Home
Sponsor:
KerNel Biomedical
Organization:
KerNel Biomedical
Study Overview
Official Title:
Evaluation of the Feasibility of Remote Monitoring of Cough Assist Devices in Paralytic and Neuromuscular Patients Treated at Home
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-INEX
Brief 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 patients 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 patients 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 ie 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 patients 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 patients 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 patients 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 devices 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
Treatment data is recorded by the machine at each MI-E session which may be daily or less frequent depending on the patients 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 patients 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 ie 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 patients 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 patients 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 patients 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 devices 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
Detailed Description:
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 eg at the providers 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
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 eg at the providers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None