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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2018

Interventions

  • Device: telemonitoring
  • Device: sham telemonitoring

Arms, Groups and Cohorts

  • Active Comparator: NIV treatment with telemonitoring
    • telemonitoring is used to manage NIV treatment
  • Sham Comparator: NIV treatment with sham telemonitoring
    • sham telemonitoring (data not used for NIV management)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thibaut Gentina, MD, Principal Investigator, Hôpital Privé la Louvière – Lille

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