Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neuromuscular Diseases
- Sponsor
- Centre d'Investigation Clinique et Technologique 805
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of required days to obtain a 4-hours-night ventilation
- Last Updated
- 9 years ago
Overview
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.
Investigators
david orlikowski
coordinating physician - professor
Centre d'Investigation Clinique et Technologique 805
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of required days to obtain a 4-hours-night ventilation
Time Frame: 5 days
Secondary Outcomes
- Number of non programmed home visits(5 days)
- Number of ventilation hours per 24 hours during the 5 first days(5 days)
- Capno-oximetry improvement at D5(5 days)
- Clinical signs decrease (symptoms, dyspnea, drowsiness)(30 days)
- Number of hospitalization for respiratory or ventilation disorder(30 days)
- Quality of life (SF36) at D1 and D30(30 days)
- Economic cost evaluation(5 days)
- Satisfaction scale for the patient and his family at D5 and D30(30 days)
- Capno-oximetry and arterial blood gases improvement at D30(30 days)
- Number of skin slough caused by interface position(30 days)
- Reliability of telemonitoring(5 days)
- Reliability of telemedicine(5 days)