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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIV treatment with telemonitoring | Active Comparator | telemonitoring is used to manage NIV treatment |
|
| NIV treatment with sham telemonitoring | Sham Comparator | sham telemonitoring (data not used for NIV management) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemonitoring | Device |
|
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Intentional leaks | 12 months | |
| Peripheral oxygen saturation (SP02) | 12 months | |
| Apnea Hypopnea Index (AHI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thibaut Gentina, MD | Hôpital Privé la Louvière - Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital privé la Louvière | Lille | 59000 | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| sham telemonitoring |
| Device |
|
|
| 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 |
| Epworth Sleepiness Scale (ESS) | 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |