Kyphoscoliosis, Neuromuscular Diseases, Non Invasive Ventilation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHome NIV installation
Sponsors
Centre d'Investigation Clinique et Technologique 805
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man or Women aged over 18 years * Neuromuscular disease or kyphoscoliosis * At least one sign among : dyspnea, orthopnea, daytime sleepiness, cephalalgia, asthenia * At least one sign among : hypercapnia \> 45 mmHg, desaturation time \< 88%, night desaturation time \> 5 min, Vital Capacity \< 60% or Pimax \< 60 cm H2O.
Exclusion criteria
* Mechanic ventilation refusal * Patient living alone * Acute respiratory failure * Patient who need a third party for the ventilation installation * Severe respiratory limitation * Home oxygen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of required days to obtain a 4-hours-night ventilation | 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Capno-oximetry improvement at D5 | 5 days | — |
| Capno-oximetry and arterial blood gases improvement at D30 | 30 days | — |
| Clinical signs decrease (symptoms, dyspnea, drowsiness) | 30 days | — |
| Number of non programmed home visits | 5 days | — |
| Economic cost evaluation | 5 days | — |
| Number of ventilation hours per 24 hours during the 5 first days | 5 days | — |
| Number of hospitalization for respiratory or ventilation disorder | 30 days | — |
| Satisfaction scale for the patient and his family at D5 and D30 | 30 days | CSQ8 and VAS (Visual Analogical Scale) |
| Quality of life (SF36) at D1 and D30 | 30 days | — |
| Reliability of telemonitoring | 5 days | Cross between ventilation parameters read remotely and ventilation parameters audited at patient home (by an ASV Santé employee) |
| Reliability of telemedicine | 5 days | Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee) |
| Number of skin slough caused by interface position | 30 days | — |
Countries
France
Contacts
Primary ContactDavid ORLIKOWSKI, MD Ph.D
Outcome results
None listed