Clinical trial NCT02258191: Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients
Official title: Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: NIV
COPD
telemonitoring
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution
timeFrame: 12 months
measure: Compliance evolution: mean duration usage (hour per day)
timeFrame: 12 months
Secondary outcomes:
measure: Non-Intentional leaks
timeFrame: 12 months
measure: Peripheral oxygen saturation (SP02)
timeFrame: 12 months
measure: Apnea Hypopnea Index (AHI)
timeFrame: 12 months
measure: Oxygen desaturation Index (ODI)
timeFrame: 12 months
measure: Time with peripheral oxygen saturation (SP02) < 90%
timeFrame: 12 months
measure: St Georges Quality of Life questionnaire
timeFrame: 12 months
measure: 6 Minutes Walking Test (6MWT)
timeFrame: 12 months
measure: The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index
timeFrame: 12 months
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 12 months
measure: % of patients with Ventilatory asynchronisms
timeFrame: 12 months
measure: Mean Noninvasive Ventilation (NIV) use duration (hour/day)
timeFrame: 12 months
measure: % of days with noninvasive Ventilation (NIV) use ≥ 4h/day
timeFrame: 12 months
measure: % of days with noninvasive Ventilation (NIV) use < 4h/day
timeFrame: 12 months
measure: % of days with no Noninvasive Ventilation (NIV) use
timeFrame: 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital privé la Louvière
Study officials:
affiliation: Hôpital Privé la Louvière - Lille
name: Thibaut Gentina, MD
role: PRINCIPAL_INVESTIGATOR
References: