Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation During Exercise.

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: oxygen

• Registration Number: NCT02273830
• Lead Sponsor: Jtarrega

Brief Summary

The purpose of this study is analyzed the impact of oxygen adjusted during exercise in COPD patients without conventional for LTOT but with exercise desaturation.

Detailed Description

Oxygen will be administered through nasal cannulae. Patients will be provided with a tank of liquid oxygen and a rechargeable portable device. The 6 minuts walking test will be used to adjusted oxygen flow in the GFA group (to achieve a mean SpO2 ≥ 90%). In the control group (GC), a 3L/min oxygen flow will be administer. Oxygen is used when the patient perform physical activity. The treatment period for each patient is 6 months (3 months in the GC grup, 3 months in the GFA one).

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2015-09
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Clinical stable moderate to severe COPD (FEV1 <70%, FEV 1 / FVC <70%) total lung capacity (TLC> 80%) without conventional criteria for LTOT, optimal medical therapy, mean SpO2 ≤ 88% during the 6 minuts walking test and active life outside the home, other than active smoking or are in program respiratory rehabilitation.

Exclusion Criteria

• Current smokers - Presence of respiratory failure and criteria for LTOT (PO2 <55 mmHg or 55-60 mmHg associated with pulmonary arterial hypertension, chronic cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Presence of impaired mobility - Cognitive impairment or intellectual disability to fill in questionnaires - No acceptance of liquid oxygen - Presence of active comorbidities (cardiovascular disease, rheumatologic, renal, hepatic) - Participation in pulmonary rehabilitation programs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
oxygen adjusted	oxygen	oxygen adjusted to get SpO2\> 90% during the walking test
control group	oxygen	oxygen at 3L/min

Primary Outcome Measures

Name	Time	Method
Benefits on HRQOL	3 months	The aim is to analyze the benefits on HRQOL of suitable correction of desaturation in COPD patients without conventional criteria for OCD but with exercise desaturation.

Secondary Outcome Measures

Name	Time	Method
Increase exercise capacity	3 months	Increase exercise capacity
Reduce breathlessness during exercise	3 months	Reduce breathlessness during exercise
Increasing physical activity	3 months	Increasing physical activity

Trial Locations

Locations (1)

Hospital General de Granollers; 🇪🇸 Granollers, BArcelona, Spain