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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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COPD Oxygen Therapy Hypercapnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fixed oxygen flow delivery

Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment.

Group Type ACTIVE_COMPARATOR

Manual settings with FreeO2 system in collection mode

Intervention Type DEVICE

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

FreeO2 system

FreeO2 is a new system that automatically adjusts the oxygen flow delivered to patients in a closed-loop based on the SpO2 signal. This system is intended to maintain SpO2 in a predefined target and to adapt oxygen flow to patient's needs.

Group Type EXPERIMENTAL

Automated settings on the oxygen delivery device

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Manual settings with FreeO2 system in collection mode

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

Intervention Type DEVICE

Eligibility Criteria

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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