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

August 6, 2018 updated by: Jtarrega

Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation on Exercise But Without Conventional Criteria for Domiciliary Oxygen Therapy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • BArcelona
      • Granollers, BArcelona, Spain, 08402
        • Hospital General de Granollers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oxygen adjusted
oxygen adjusted to get SpO2> 90% during the walking test
Drug: oxygen
Oxygen administered after adjustment during a waking test or at 3L/min
Placebo Comparator: control group
oxygen at 3L/min
Drug: oxygen
Oxygen administered after adjustment during a waking test or at 3L/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Benefits on HRQOL
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce breathlessness during exercise
Time Frame: 3 months
Reduce breathlessness during exercise
3 months
Increase exercise capacity
Time Frame: 3 months
Increase exercise capacity
3 months
Increasing physical activity
Time Frame: 3 months
Increasing physical activity
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jtarrega

Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Mutua de Terrassa
Hospital Universitari Sant Joan de Reus
Hospital Dos de Maig

Investigators

  • Principal Investigator: JULIA TARREGA, PhD, Hospital General de Granollers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20131001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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