Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: telemonitoring; Device: sham telemonitoring

• Registration Number: NCT02258191
• Lead Sponsor: ResMed

Brief Summary

Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.

Multicentric Randomized Controlled Trial

Primary Objective:

To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance

Secondary Objectives:

To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-07
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• COPD patient already treated by NIV requiring therapy assessment in their routine care Follow-Up or
• COPD patient requiring de Novo NIV therapy according to routine care rules (NIV<12h)
• Patient requiring NIV therapy by S9 VPAP ST +/- oxygen therapy
• Patient willing to participate to the study
• Patient or attendant able to complete patient passport and to come to Follow-Up visits.

Exclusion Criteria

• NIV therapy Failure during screening phase (intolerance, patient refusal, significant leaks, significant AHI or Oxymetry events)
• Hospitalization conducting to NIV discontinuation for at least 1 week during the screening phase

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV treatment with telemonitoring	telemonitoring	telemonitoring is used to manage NIV treatment
NIV treatment with sham telemonitoring	sham telemonitoring	sham telemonitoring (data not used for NIV management)

Primary Outcome Measures

Name	Time	Method
Compliance evolution: mean duration usage (hour per day)	12 months
Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution	12 months

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	12 months
Apnea Hypopnea Index (AHI)	12 months
St Georges Quality of Life questionnaire	12 months
Peripheral oxygen saturation (SP02)	12 months
Oxygen desaturation Index (ODI)	12 months
6 Minutes Walking Test (6MWT)	12 months
% of patients with Ventilatory asynchronisms	12 months
Time with peripheral oxygen saturation (SP02) < 90%	12 months
Non-Intentional leaks	12 months
The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index	12 months
Mean Noninvasive Ventilation (NIV) use duration (hour/day)	12 months
% of days with noninvasive Ventilation (NIV) use ≥ 4h/day	12 months
% of days with noninvasive Ventilation (NIV) use < 4h/day	12 months
% of days with no Noninvasive Ventilation (NIV) use	12 months

Trial Locations

Locations (1)

Hôpital privé la Louvière; 🇫🇷 Lille, France