COPD
Conditions
Keywords
NIV, COPD, telemonitoring
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
Interventions
DEVICEtelemonitoring
DEVICEsham telemonitoring
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution | 12 months |
| Compliance evolution: mean duration usage (hour per day) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Apnea Hypopnea Index (AHI) | 12 months |
| Oxygen desaturation Index (ODI) | 12 months |
| Time with peripheral oxygen saturation (SP02) < 90% | 12 months |
| St Georges Quality of Life questionnaire | 12 months |
| 6 Minutes Walking Test (6MWT) | 12 months |
| The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index | 12 months |
| Non-Intentional leaks | 12 months |
| % of patients with Ventilatory asynchronisms | 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 |
| Epworth Sleepiness Scale (ESS) | 12 months |
| Peripheral oxygen saturation (SP02) | 12 months |
Countries
France
Outcome results
None listed