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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273830
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Mutua de Terrassa
Hospital Dos de Maig
Hospital Universitari Sant Joan de Reus
Information provided by (Responsible Party):
Jtarrega, Hospital de Granollers

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: oxygen Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Benefits of Liquid Oxygen in COPD Patients Presenting Desaturation on Exercise But Without Conventional Criteria for Domiciliary Oxygen Therapy.
Study Start Date : September 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reduce breathlessness during exercise [ Time Frame: 3 months ]
    Reduce breathlessness during exercise

  2. Increase exercise capacity [ Time Frame: 3 months ]
    Increase exercise capacity

  3. Increasing physical activity [ Time Frame: 3 months ]
    Increasing physical activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273830


Locations
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Spain
Hospital General de Granollers
Granollers, BArcelona, Spain, 08402
Sponsors and Collaborators
Jtarrega
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Mutua de Terrassa
Hospital Dos de Maig
Hospital Universitari Sant Joan de Reus
Investigators
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Principal Investigator: JULIA TARREGA, PhD Hospital general de Granollers

Publications:
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Responsible Party: Jtarrega, PhD, Hospital de Granollers
ClinicalTrials.gov Identifier: NCT02273830    
Other Study ID Numbers: 20131001
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Keywords provided by Jtarrega, Hospital de Granollers:
oxygen therapy
COPD
exercise
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive