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

COPD Clinical Trial

— FreeO2-rehab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575327
• Other study ID #: 11-AGIR-01
• Status: Completed
• Phase: N/A
• First received: March 13, 2012
• Last updated: March 13, 2018
• Start date: July 2012
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Hypercapnia
• Oxygen Therapy
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• Manual settings with FreeO2 system in collection mode
FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters

Locations

Country	Name	City	State
France	Hopital Universitaire	Grenoble
France	Centre ATRIR	Nyons
France	Centre Henri BAZIRE	Saint-Julien-de-Raz

Sponsors (2)

Lead Sponsor	Collaborator
AGIR à Dom	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endurance time	Duration during the endurance shuttle walking test	Day 0 (inclusion) + 14 and D0 +21
Secondary	Change in Dyspnea during ESWT	Visual analogic scores of dyspnea during the endurance shuttle walking test	Day 0 (inclusion) + 14 and D0 +21
Secondary	Change in Muscle fatigue during ESWT	Visual analogic scores of leg discomfort during the endurance shuttle walking test	Day 0 (inclusion) + 14 and D0 +21
Secondary	Change in Respiratory frequency during ESWT	Respiratory frequency measurement by the FreeO2 system during the endurance shuttle walking test	Day 0 (inclusion) + 14 and D0 +21
Secondary	Change in PaCO2 during ESWT	EtCO2 measurement by the FreeO2 system during the endurance shuttle walking test	Day 0 (inclusion) + 14 and D0 +21
Secondary	Hypercapnia level at baseline	Blood gases at rest	Day 0 (inclusion) - baseline evaluation
Secondary	Change in Cardiac frequency during ESWT	Cardiac frequency measurement by the FreeO2 system during the endurance shuttle walking test	Day 0 (inclusion) + 14 and D0 +21
Secondary	Change in SpO2 during ESWT	Pulse oxygen saturation during the endurance shuttle walking test	Day 0 (inclusion) + 14 and D0 +21