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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Neuromuscular Diseases Kyphoscoliosis Non Invasive Ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home NIV installation

Group Type EXPERIMENTAL

Home NIV installation

Intervention Type DEVICE

Interventions

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Home NIV installation

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No