Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance (Tele-VAD)
Neuromuscular diseases are frequently associated with respiratory failure, which requires Non Invasive Ventilation (NIV). Currently, the NIV installation is done during an hospitalization of several days. This hospitalization is problematic because of availability of beds, logistical difficulties for the patient and estrangement from the usual environment.
For this reasons, the NIV installation at home could be an interesting alternative for both the patient and the medical staff.
The aim of this pilot study is to test the feasibility of NIV installation at home, using telemedicine as a remote monitoring tool, and to assess its impact on the ventilation compliance.
Non Invasive Ventilation
Device: Home NIV installation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance|
- Number of required days to obtain a 4-hours-night ventilation [ Time Frame: 5 days ]
- Number of ventilation hours per 24 hours during the 5 first days [ Time Frame: 5 days ]
- Capno-oximetry improvement at D5 [ Time Frame: 5 days ]
- Capno-oximetry and arterial blood gases improvement at D30 [ Time Frame: 30 days ]
- Clinical signs decrease (symptoms, dyspnea, drowsiness) [ Time Frame: 30 days ]
- Number of non programmed home visits [ Time Frame: 5 days ]
- Economic cost evaluation [ Time Frame: 5 days ]
- Number of skin slough caused by interface position [ Time Frame: 30 days ]
- Number of hospitalization for respiratory or ventilation disorder [ Time Frame: 30 days ]
- Satisfaction scale for the patient and his family at D5 and D30 [ Time Frame: 30 days ]CSQ8 and VAS (Visual Analogical Scale)
- Quality of life (SF36) at D1 and D30 [ Time Frame: 30 days ]
- Reliability of telemonitoring [ Time Frame: 5 days ]Cross between ventilation parameters read remotely and ventilation parameters audited at patient home (by an ASV Santé employee)
- Reliability of telemedicine [ Time Frame: 5 days ]Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee)
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
For the study protocol, patients will be hospitalized for the first day to define the ventilation mode and initial parameters, and to choose the best adapted interface.
Then, the patient is discharged from hospital and parameters adaptation is continued at home during the following five days by the hospital medical staff, using telemedicine. An ASV Santé employee visits the patient at home everyday during 5 days to ensure follow-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02103790
|Contact: David ORLIKOWSKI, MD Ph.D||01 47 10 77 firstname.lastname@example.org|
|Hôpital Raymond Poincaré||Recruiting|
|Garches, France, 92380|
|Contact: David ORLIKOWSKI, Ph.D MD 33(0) 147107777 email@example.com|
|Sub-Investigator: Adam OGNA, MD|
|Principal Investigator: David ORLIKOWSKI, Ph.D MD|
|Sub-Investigator: Hélène PRIGENT, MD Ph.D|
|Sub-Investigator: Maria Antonia QUERA SALVA, MD|