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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)

This study is currently recruiting participants.
Verified March 2017 by david orlikowski, Centre d'Investigation Clinique et Technologique 805
Sponsor:
ClinicalTrials.gov Identifier:
NCT02103790
First Posted: April 4, 2014
Last Update Posted: March 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
david orlikowski, Centre d'Investigation Clinique et Technologique 805
  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: Intervention Model: Single Group Assignment
Masking: None (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 david orlikowski, 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 ]

Secondary Outcome Measures:
  • Number of ventilation hours per 24 hours during the 5 first days [ Time Frame: 5 days ]
  • Capno-oximetry improvement at D5 [ Time Frame: 5 days ]
  • Capno-oximetry and arterial blood gases improvement at D30 [ Time Frame: 30 days ]
  • Clinical signs decrease (symptoms, dyspnea, drowsiness) [ Time Frame: 30 days ]
  • Number of non programmed home visits [ Time Frame: 5 days ]
  • Economic cost evaluation [ Time Frame: 5 days ]
  • Number of skin slough caused by interface position [ Time Frame: 30 days ]
  • Number of hospitalization for respiratory or ventilation disorder [ Time Frame: 30 days ]
  • Satisfaction scale for the patient and his family at D5 and D30 [ Time Frame: 30 days ]
    CSQ8 and VAS (Visual Analogical Scale)

  • Quality of life (SF36) at D1 and D30 [ Time Frame: 30 days ]
  • Reliability of telemonitoring [ Time Frame: 5 days ]
    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 ]
    Cross between ventilation parameters modified remotely and ventilation parameters audited at patient home (by an ASV Santé employee)


Estimated Enrollment: 20
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103790


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

Locations
France
Hôpital Raymond Poincaré 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

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
First Submitted: April 1, 2014
First Posted: April 4, 2014
Last Update Posted: March 9, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases