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

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.

Study Overview

• Status: Unknown
• Conditions: Neuromuscular Diseases; Kyphoscoliosis; Non Invasive Ventilation
• Intervention / Treatment: Device: Home NIV installation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Hopital Raymond Poincare
    • Sub-Investigator: Adam OGNA, MD
    • Contact: David ORLIKOWSKI, Ph.D MD; Phone Number: 33(0) 147107777; Email: david.orlikowski@rpc.aphp.fr
    • Principal Investigator: David ORLIKOWSKI, Ph.D MD
    • Sub-Investigator: Hélène PRIGENT, MD Ph.D
    • Sub-Investigator: Maria Antonia QUERA SALVA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home NIV installation	Device: Home NIV installation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 2013-A01817-38