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

Neuromuscular Diseases Clinical Trial

— Tele-VAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02103790
• Other study ID #: 2013-A01817-38
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2014
• Last updated: March 8, 2017
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: David ORLIKOWSKI, MD Ph.D
• Phone: 01 47 10 77 77
• Email: david.orlikowski[@]rpc.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kyphoscoliosis
• Neuromuscular Diseases
• Non Invasive Ventilation

Intervention

Device:
• Home NIV installation

Locations

Country	Name	City	State
France	Hôpital Raymond Poincaré	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

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