Skip to main content
OpenTrials
Completed

NCT Number: NCT02258191

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital privé la Louvière

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring

Device

Other names: Easy Care online

sham telemonitoring

Device

Other names: Easy Care online

Primary outcomes

  1. Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution

    Time frame: 12 months

  2. Compliance evolution: mean duration usage (hour per day)

    Time frame: 12 months

Secondary outcomes

  1. Non-Intentional leaks

    Time frame: 12 months

  2. Peripheral oxygen saturation (SP02)

    Time frame: 12 months

  3. Apnea Hypopnea Index (AHI)

    Time frame: 12 months

  4. Oxygen desaturation Index (ODI)

    Time frame: 12 months

  5. Time with peripheral oxygen saturation (SP02) < 90%

    Time frame: 12 months

  6. St Georges Quality of Life questionnaire

    Time frame: 12 months

  7. 6 Minutes Walking Test (6MWT)

    Time frame: 12 months

  8. The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index

    Time frame: 12 months

  9. Epworth Sleepiness Scale (ESS)

    Time frame: 12 months

  10. % of patients with Ventilatory asynchronisms

    Time frame: 12 months

  11. Mean Noninvasive Ventilation (NIV) use duration (hour/day)

    Time frame: 12 months

  12. % of days with noninvasive Ventilation (NIV) use ≥ 4h/day

    Time frame: 12 months

  13. % of days with noninvasive Ventilation (NIV) use < 4h/day

    Time frame: 12 months

  14. % of days with no Noninvasive Ventilation (NIV) use

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Acronym: eCOPD

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 7, 2014
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.