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

Not Applicable

• Conditions: Neuromuscular Diseases; Kyphoscoliosis; Non Invasive Ventilation
• Interventions: Device: Home NIV installation

• Registration Number: NCT02103790
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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.

Study Timeline

• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Study Start: 2015-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-09
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home NIV installation	Home NIV installation	-

Primary Outcome Measures

Name	Time	Method
Number of required days to obtain a 4-hours-night ventilation	5 days

Secondary Outcome Measures

Name	Time	Method
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	CSQ8 and VAS (Visual Analogical Scale)
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	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)

Trial Locations

Locations (1)

Hôpital Raymond Poincaré; 🇫🇷 Garches, France