Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance

Conditions
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Neuromuscular Diseases, Kyphoscoliosis, Non Invasive Ventilation

Intervention / Treatment
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* Device: Home NIV installation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home NIV installation<br> | Device: Home NIV installation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of required days to obtain a 4-hours-night ventilation |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilation hours per 24 hours during the 5 first days |  | 5 days | 
| 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 skin slough caused by interface position |  | 30 days | 
| Number of hospitalization for respiratory or ventilation disorder |  | 30 days | 
| Satisfaction scale for the patient and his family at D5 and D30 | CSQ8 and VAS (Visual Analogical Scale) | 30 days | 
| Quality of life (SF36) at D1 and D30 |  | 30 days | 
| Reliability of telemonitoring | Cross between ventilation parameters read remotely and ventilation parameters audited at patient home (by an ASV Santé employee) | 5 days | 
| Reliability of telemedicine | Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee) | 5 days |