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Completed

NCT Number: NCT01575327

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Hypercapnia Lung Diseases Lung Diseases, Obstructive Oxygen Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Universitaire, Grenoble, France

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About this study

Background:

In spite of oxygen therapy, desaturations frequently occur during exercise in COPD patients. Although current recommendations are to add 1 L/min to the baseline oxygen flow during exertion, a new closed-loop system (FreeO2) automatically and continuously adjusts the oxygen flow to the patient's needs based on the oxygen saturation by pulse oximetry (SpO2), end-tidal CO2 (EtCO2) and respiratory rate. A preliminary study showed significant improvement in exercise tolerance in COPD patients not needing oxygen therapy. Although oxygen flow could be two fold increased during exercise, a worsening hypercapnia is plausible in severe COPD.

Aim of this study is to evaluate this system during endurance shuttle walking test in COPD patients with oxygen therapy and hypercapnia.

Methods: The investigators proposed to conduct a controlled, randomized cross-over study comparing the efficacy of a Closed-loop System for Oxygen Delivery (FreeO2) as compared with fixed oxygen flow during an endurance shuttle walking test in patients with COPD, oxygen therapy and hypercapnia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 40 Years and older
  • Patient with COPD severe to very severe requiring long-term Oxygen Therapy
  • Hypercapnia (PaCO2 > 45mmHg)
  • Former or current smoker greater than or equal to 10 pack-years

Exclusion criteria

  • Pregnant or breast-feed woman
  • Patients under guardianship
  • Imprisoned patients

Treatment and study plan

Automated settings on the oxygen delivery device

Device

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

Manual settings with FreeO2 system in collection mode

Device

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

Primary outcomes

  1. Change in Endurance time

    Time frame: Day 0 (inclusion) + 14 and D0 +21

    Duration during the endurance shuttle walking test

Secondary outcomes

  1. Change in Dyspnea during ESWT

    Time frame: Day 0 (inclusion) + 14 and D0 +21

    Visual analogic scores of dyspnea during the endurance shuttle walking test

  2. Change in Muscle fatigue during ESWT

    Time frame: Day 0 (inclusion) + 14 and D0 +21

    Visual analogic scores of leg discomfort during the endurance shuttle walking test

  3. Change in Respiratory frequency during ESWT

    Time frame: Day 0 (inclusion) + 14 and D0 +21

    Respiratory frequency measurement by the FreeO2 system during the endurance shuttle walking test

  4. Change in PaCO2 during ESWT

    Time frame: Day 0 (inclusion) + 14 and D0 +21

    EtCO2 measurement by the FreeO2 system during the endurance shuttle walking test

  5. Hypercapnia level at baseline

    Time frame: Day 0 (inclusion) - baseline evaluation

    Blood gases at rest

  6. Change in Cardiac frequency during ESWT

    Time frame: Day 0 (inclusion) + 14 and D0 +21

    Cardiac frequency measurement by the FreeO2 system during the endurance shuttle walking test

  7. Change in SpO2 during ESWT

    Time frame: Day 0 (inclusion) + 14 and D0 +21

    Pulse oxygen saturation during the endurance shuttle walking test

Sponsors and collaborators

Lead sponsor

AGIR à Dom

Other

Collaborators

  • University Hospital, Grenoble

Registry information

Official study title

Using a Closed-loop System for Oxygen Delivery (FreeO2) to Optimize Exercise Tolerance During Walk in Patients With COPD, Oxygen Therapy and Hypercapnia

Acronym: FreeO2-rehab

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2012
Registry last updated
Mar 14, 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.

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