A clinical, prospective, randomized controlled trial to determine the effect of prescribing oxygen in a group of COPD (chronic pulmonary disease) patients with PaO2 (arterial oxygen tension) ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on echocardiogram (which are considered manifestations of chronic hypoxia)
A clinical, prospective, randomized controlled trial to determine the effect of prescribing oxygen in a group of COPD patients with PaO2 ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on echocardiogram (which are considered manifestations of chronic hypoxia). It will be included 220 patients of the Fundación Neumológica Colombiana living in Bogotá who accept their participation by signing an informed consent. The subjects will be randomly assigned to receive or not LTOT and they will be followed for 20 to 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE) and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of life, lung function, neurocognitive performance and exercise tolerance by comparing the groups with and without LTOT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
220
The subjects will be randomly assigned to receive or not LTOT and they will be followed for 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE) and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of life, lung function, neurocognitive performance and exercise tolerance by comparing the groups with and without LTOT.
Fundación Neumológica Colombiana
Bogotá, Colombia
Development of pulmonary hypertension
An echocardiogram will be conducted every ten months to measure the value of pulmonary artery pressure and establish the presence of pulmonary hypertension
Time frame: 3 years
Development of polycythemia
A sample of hematocrit and hemoglobine will be perfomed to establish the presence of polycythemia at the begining of the study and every 10 months.
Time frame: 3 years
Evaluation of the pulmonary function
Spirometry will be conducted to assess the Forced expiratory volume at 1 second and the Forced vital capacity at the begining of the study and every 10 months.
Time frame: 3 years
Number of exacerbations
It will report the number of exacerbations that present the patients during the study
Time frame: 3 years
Evaluation of the quality of life
It will perform the St. George Respiratory Questionnaire (SGRQ) to assess the quality of life of the patients at the begining of the study and every 10 months.
Time frame: 3 years
Assessment of neurocognitive function
It will make a Mini mental Test to evaluate the neurocognitive performance at the begining of the study and every 10 months.
Time frame: 3 years
Evaluation of exercise tolerance
It will conduct a six minute walk test to assess the exercise tolerance at the the begining of the study and every 10 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 years