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Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease

NCT01575327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-03-14

No results posted yet for this study

Summary

The purpose of this study is to investigate the benefit of Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with Chronic obstructive pulmonary disease (COPD), oxygen therapy and hypercapnia.

The study was designed to test the following hypotheses:

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to higher exercise tolerance (distance during ESWT) and lower desaturation events without increase in hypercapnia in patients with COPD, oxygen therapy and hypercapnia.

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower dyspnea and leg fatigue scores at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

As compared with fixed oxygen flow, the FreeO2 Oxygen Delivery system leads to lower cardiac and respiratory frequencies at a given endurance time during the shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

Conditions

  • COPD
  • Oxygen Therapy
  • Hypercapnia

Interventions

DEVICE

Automated settings on the oxygen delivery device

FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters

DEVICE

Manual settings with FreeO2 system in collection mode

FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER

  • AGIR à Dom

    lead OTHER

Principal Investigators

  • Jean-Louis Pepin, MD, PhD · Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01575327 on ClinicalTrials.gov