Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01575327
Other study ID # 11-AGIR-01
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06000696 - Healthy at Home Pilot
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04105075 - COPD in Obese Patients
Recruiting NCT05825261 - Exploring Novel Biomarkers for Emphysema Detection
Active, not recruiting NCT04075331 - Mepolizumab for COPD Hospital Eosinophilic Admissions Pragmatic Trial Phase 2/Phase 3
Terminated NCT03640260 - Respiratory Regulation With Biofeedback in COPD N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
Withdrawn NCT04210050 - Sleep Ventilation for Patients With Advanced Hypercapnic COPD N/A
Terminated NCT03284203 - Feasibility of At-Home Handheld Spirometry N/A
Recruiting NCT06110403 - Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness Phase 1/Phase 2
Active, not recruiting NCT06040424 - Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Completed NCT01892566 - Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV N/A
Completed NCT04119856 - Outgoing Lung Team - a Cross-sectorial Intervention in Patients With COPD N/A
Completed NCT04485741 - Strados System at Center of Excellence
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Recruiting NCT04860375 - Multidisciplinary Management of Severe COPD N/A