Clinical trial NCT02103790: Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
Official title: Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neuromuscular Diseases
Kyphoscoliosis
Non Invasive Ventilation
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of required days to obtain a 4-hours-night ventilation
timeFrame: 5 days
Secondary outcomes:
measure: Number of ventilation hours per 24 hours during the 5 first days
timeFrame: 5 days
measure: Capno-oximetry improvement at D5
timeFrame: 5 days
measure: Capno-oximetry and arterial blood gases improvement at D30
timeFrame: 30 days
measure: Clinical signs decrease (symptoms, dyspnea, drowsiness)
timeFrame: 30 days
measure: Number of non programmed home visits
timeFrame: 5 days
measure: Economic cost evaluation
timeFrame: 5 days
measure: Number of skin slough caused by interface position
timeFrame: 30 days
measure: Number of hospitalization for respiratory or ventilation disorder
timeFrame: 30 days
measure: Satisfaction scale for the patient and his family at D5 and D30
timeFrame: 30 days
measure: Quality of life (SF36) at D1 and D30
timeFrame: 30 days
measure: Reliability of telemonitoring
timeFrame: 5 days
measure: Reliability of telemedicine
timeFrame: 5 days
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
References: