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

NCT02258191 | Completed

• 1 other identifier: eCOPD 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

COPD

Keywords

NIV; COPD; telemonitoring

Outcome Measures

Primary Outcomes (2)

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

  12 months

• Compliance evolution: mean duration usage (hour per day)

  12 months

Secondary Outcomes (14)

• Non-Intentional leaks

  12 months

• Peripheral oxygen saturation (SP02)

  12 months

• Apnea Hypopnea Index (AHI)

  12 months

• Oxygen desaturation Index (ODI)

  12 months

• Time with peripheral oxygen saturation (SP02) < 90%

  12 months

Study Arms (2)

NIV treatment with telemonitoring

ACTIVE COMPARATOR

telemonitoring is used to manage NIV treatment

Device: telemonitoring

NIV treatment with sham telemonitoring

SHAM COMPARATOR

sham telemonitoring (data not used for NIV management)

Device: sham telemonitoring

Interventions

telemonitoring DEVICE

Also known as: Easy Care online

NIV treatment with telemonitoring

sham telemonitoring DEVICE

Also known as: Easy Care online

NIV treatment with sham telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Hôpital privé la Louvière

Lille, 59000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thibaut Gentina, MD

  Hôpital Privé la Louvière - Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 7, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

FR (1)