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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Information provided by (Responsible Party):
david orlikowski, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT02103790
First received: April 1, 2014
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Neuromuscular Diseases
Kyphoscoliosis
Non Invasive Ventilation
Device: Home NIV installation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • Number of required days to obtain a 4-hours-night ventilation [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of ventilation hours per 24 hours during the 5 first days [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Capno-oximetry improvement at D5 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Capno-oximetry and arterial blood gases improvement at D30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Clinical signs decrease (symptoms, dyspnea, drowsiness) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of non programmed home visits [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Economic cost evaluation [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Number of skin slough caused by interface position [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Number of hospitalization for respiratory or ventilation disorder [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Satisfaction scale for the patient and his family at D5 and D30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    CSQ8 and VAS (Visual Analogical Scale)

  • Quality of life (SF36) at D1 and D30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Reliability of telemonitoring [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Cross between ventilation parameters read remotely and ventilation parameters audited at patient home (by an ASV Santé employee)

  • Reliability of telemedicine [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee)


Estimated Enrollment: 20
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home NIV installation 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02103790

Contacts
Contact: David ORLIKOWSKI, MD Ph.D 01 47 10 77 77 david.orlikowski@rpc.aphp.fr

Locations
France
Hôpital Raymond Poincaré Not yet recruiting
Garches, France, 92380
Contact: David ORLIKOWSKI, Ph.D MD    33(0) 147107777    david.orlikowski@rpc.aphp.fr   
Sub-Investigator: Adam OGNA, MD         
Principal Investigator: David ORLIKOWSKI, Ph.D MD         
Sub-Investigator: Hélène PRIGENT, MD Ph.D         
Sub-Investigator: Maria Antonia QUERA SALVA, MD         
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
  More Information

No publications provided

Responsible Party: david orlikowski, coordinating physician - professor, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02103790     History of Changes
Other Study ID Numbers: 2013-A01817-38
Study First Received: April 1, 2014
Last Updated: July 24, 2014
Health Authority: France : ANSM - FRENCH HEALTH PRODUCTS AGENCY

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014