Closed-loop System for Oxygen Delivery and Exercise in Chronic Obstructive Pulmonary Disease (FreeO2-rehab)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 majoration of 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.
| Condition | Intervention |
|---|---|
|
COPD Oxygen Therapy Hypercapnia |
Device: Automated settings on the oxygen delivery device Device: Manual settings with FreeO2 system in collection mode |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Change in Endurance time [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]Duration during the endurance shuttle walking test
- Change in Dyspnea during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]Visual analogic scores of dyspnea during the endurance shuttle walking test
- Change in Muscle fatigue during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]Visual analogic scores of leg disconfort during the endurance shuttle walking test
- Change in Respiratory frequency during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]Respiratory frequency measurement by the FreeO2 system during the endurance shuttle walking test
- Change in Capnia during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]EtCO2 measurement by the FreeO2 system during the endurance shuttle walking test
- Hypercapnia level at baseline [ Time Frame: Day 0 (inclusion) - baseline evaluation ] [ Designated as safety issue: No ]Blood gases at rest
- Change in Cardiac frequency during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]Cardiac frequency measurement by the FreeO2 system during the endurance shuttle walking test
- Change in SpO2 during ESWT [ Time Frame: Day 0 (inclusion) + 14 and D0 +21 ] [ Designated as safety issue: No ]Pulse oxygen saturation during the endurance shuttle walking test
| Estimated Enrollment: | 12 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Fixed oxygen flow delivery
Oxygen flow delivery is adjusted by respiratory therapists. Standard medical treatment.
|
Device: Manual settings with FreeO2 system in collection mode
FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters
|
|
Experimental: 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.
|
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
|
Detailed Description:
Background:
In spite of oxygen therapy, desaturations frequently occur during exercise in COPD patients. Although current recommendations are to add 1L/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 SpO2, 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| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 40 Years and older
- Patient with COPD severe to very severe requiring long-term Oxygen Therapy
- Hypercania (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
Contacts and Locations| Contact: Jean-Louis Pepin, MD, PhD | 0476765516 | JPepin@chu-grenoble.fr |
| Contact: Isabelle Vivodtzev, PhD | 0476510304 | i.vivodtzev@agiradom.com |
| France | |
| Hopital Universitaire | Recruiting |
| Grenoble, France | |
| Contact: Jean-Louis Pepin, MD, PhD 0476765516 JPepin@chu-grenoble.fr | |
| Contact: Isabelle , Vivodtzev, PhD 0476510304 i.vivodtzev@agiradom.com | |
| Principal Investigator: | Jean-Louis Pepin, MD, PhD | Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France |
More Information
No publications provided
| Responsible Party: | AGIR à Dom |
| ClinicalTrials.gov Identifier: | NCT01575327 History of Changes |
| Other Study ID Numbers: | 11-AGIR-01 |
| Study First Received: | March 13, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Hypercapnia Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive |
Signs and Symptoms, Respiratory Signs and Symptoms Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013