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

COPD Clinical Trial

— eCOPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258191
• Other study ID #: eCOPD 001
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: January 22, 2018
• Start date: July 2014
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• telemonitoring

• sham telemonitoring

Locations

Country	Name	City	State
France	Hôpital privé la Louvière	Lille

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution		12 months
Primary	Compliance evolution: mean duration usage (hour per day)		12 months
Secondary	Non-Intentional leaks		12 months
Secondary	Peripheral oxygen saturation (SP02)		12 months
Secondary	Apnea Hypopnea Index (AHI)		12 months
Secondary	Oxygen desaturation Index (ODI)		12 months
Secondary	Time with peripheral oxygen saturation (SP02) < 90%		12 months
Secondary	St Georges Quality of Life questionnaire		12 months
Secondary	6 Minutes Walking Test (6MWT)		12 months
Secondary	The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index		12 months
Secondary	Epworth Sleepiness Scale (ESS)		12 months
Secondary	% of patients with Ventilatory asynchronisms		12 months
Secondary	Mean Noninvasive Ventilation (NIV) use duration (hour/day)		12 months
Secondary	% of days with noninvasive Ventilation (NIV) use = 4h/day		12 months
Secondary	% of days with noninvasive Ventilation (NIV) use < 4h/day		12 months
Secondary	% of days with no Noninvasive Ventilation (NIV) use		12 months