Installation of Non-invasive Ventilation at Home Using Telemedicine : a Pilot Study on Feasibility and Impact on Ventilation Compliance
Tele-VAD
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 9, 2017
March 1, 2017
2.8 years
April 1, 2014
March 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of required days to obtain a 4-hours-night ventilation
5 days
Secondary Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (1)
Home NIV installation
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Mechanic ventilation refusal
- Patient living alone
- Acute respiratory failure
- Patient who need a third party for the ventilation installation
- Severe respiratory limitation
- Home oxygen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Raymond Poincaré
Garches, 92380, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- coordinating physician - professor
Study Record Dates
First Submitted
April 1, 2014
First Posted
April 4, 2014
Study Start
January 1, 2015
Primary Completion
November 1, 2017
Study Completion
December 1, 2017
Last Updated
March 9, 2017
Record last verified: 2017-03