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

Primary Purpose

Neuromuscular Diseases, Kyphoscoliosis, Non Invasive Ventilation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Home NIV installation
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Raymond PoincaréRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home NIV installation

Arm Description

Outcomes

Primary Outcome Measures

Number of required days to obtain a 4-hours-night ventilation

Secondary Outcome Measures

Number of ventilation hours per 24 hours during the 5 first days
Capno-oximetry improvement at D5
Capno-oximetry and arterial blood gases improvement at D30
Clinical signs decrease (symptoms, dyspnea, drowsiness)
Number of non programmed home visits
Economic cost evaluation
Number of skin slough caused by interface position
Number of hospitalization for respiratory or ventilation disorder
Satisfaction scale for the patient and his family at D5 and D30
CSQ8 and VAS (Visual Analogical Scale)
Quality of life (SF36) at D1 and D30
Reliability of telemonitoring
Cross between ventilation parameters read remotely and ventilation parameters audited at patient home (by an ASV Santé employee)
Reliability of telemedicine
Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee)

Full Information

First Posted
April 1, 2014
Last Updated
March 8, 2017
Sponsor
Centre d'Investigation Clinique et Technologique 805
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1. Study Identification

Unique Protocol Identification Number
NCT02103790
Brief Title
Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
Acronym
Tele-VAD
Official Title
Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases, Kyphoscoliosis, Non Invasive Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home NIV installation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Home NIV installation
Primary Outcome Measure Information:
Title
Number of required days to obtain a 4-hours-night ventilation
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Number of ventilation hours per 24 hours during the 5 first days
Time Frame
5 days
Title
Capno-oximetry improvement at D5
Time Frame
5 days
Title
Capno-oximetry and arterial blood gases improvement at D30
Time Frame
30 days
Title
Clinical signs decrease (symptoms, dyspnea, drowsiness)
Time Frame
30 days
Title
Number of non programmed home visits
Time Frame
5 days
Title
Economic cost evaluation
Time Frame
5 days
Title
Number of skin slough caused by interface position
Time Frame
30 days
Title
Number of hospitalization for respiratory or ventilation disorder
Time Frame
30 days
Title
Satisfaction scale for the patient and his family at D5 and D30
Description
CSQ8 and VAS (Visual Analogical Scale)
Time Frame
30 days
Title
Quality of life (SF36) at D1 and D30
Time Frame
30 days
Title
Reliability of telemonitoring
Description
Cross between ventilation parameters read remotely and ventilation parameters audited at patient home (by an ASV Santé employee)
Time Frame
5 days
Title
Reliability of telemedicine
Description
Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee)
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David ORLIKOWSKI, MD Ph.D
Phone
01 47 10 77 77
Email
david.orlikowski@rpc.aphp.fr
Facility Information:
Facility Name
Hôpital Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David ORLIKOWSKI, Ph.D MD
Phone
33(0) 147107777
Email
david.orlikowski@rpc.aphp.fr
First Name & Middle Initial & Last Name & Degree
Adam OGNA, MD
First Name & Middle Initial & Last Name & Degree
David ORLIKOWSKI, Ph.D MD
First Name & Middle Initial & Last Name & Degree
Hélène PRIGENT, MD Ph.D
First Name & Middle Initial & Last Name & Degree
Maria Antonia QUERA SALVA, MD

12. IPD Sharing Statement

Learn more about this trial

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

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