Clinical trial NCT01575327: Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Oxygen Therapy
Hypercapnia
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
First posted: 2012-04-11
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Endurance time
timeFrame: Day 0 (inclusion) + 14 and D0 +21
Secondary outcomes:
measure: Change in Dyspnea during ESWT
timeFrame: Day 0 (inclusion) + 14 and D0 +21
measure: Change in Muscle fatigue during ESWT
timeFrame: Day 0 (inclusion) + 14 and D0 +21
measure: Change in Respiratory frequency during ESWT
timeFrame: Day 0 (inclusion) + 14 and D0 +21
measure: Change in PaCO2 during ESWT
timeFrame: Day 0 (inclusion) + 14 and D0 +21
measure: Hypercapnia level at baseline
timeFrame: Day 0 (inclusion) - baseline evaluation
measure: Change in Cardiac frequency during ESWT
timeFrame: Day 0 (inclusion) + 14 and D0 +21
measure: Change in SpO2 during ESWT
timeFrame: Day 0 (inclusion) + 14 and D0 +21
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Hopital Universitaire
city: Nyons
country: France
facility: Centre ATRIR
city: Saint-Julien-de-Raz
country: France
facility: Centre Henri BAZIRE
Study officials:
affiliation: Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
name: Jean-Louis Pepin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thorax. 2019 Mar;74(3):298-301. doi: 10.1136/thoraxjnl-2018-211967. Epub 2018 Aug 30.