A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation

Abstract

BACKGROUND Long-term treatment with supplemental oxygen has unknown efficacy in patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation. METHODS We originally designed the trial to test whether long-term treatment with supplemental oxygen would result in a longer time to death than no use of supplemental oxygen among patients who had stable COPD with moderate resting desaturation (oxyhemoglobin saturation as measured by pulse oximetry [SpO2], 89 to 93%). After 7 months and the randomization of 34 patients, the trial was redesigned to also include patients who had stable COPD with moderate exercise-induced desaturation (during the 6-minute walk test, SpO2 ≥80% for ≥5 minutes and <90% for ≥10 seconds) and to incorporate the time to the first hospitalization for any cause into the new composite primary outcome. Patients were randomly assigned, in a 1:1 ratio, to receive long-term supplemental oxygen (supplemental-oxygen group) or no long-term supplemental oxygen (no-supplemental-oxygen group). In the supplemental-oxygen group, patients with resting desaturation were prescribed 24-hour oxygen, and those with desaturation only during exercise were prescribed oxygen during exercise and sleep. The trial-group assignment was not masked. RESULTS A total of 738 patients at 42 centers were followed for 1 to 6 years. In a time-to-event analysis, we found no significant difference between the supplemental-oxygen group and the no-supplemental-oxygen group in the time to death or first hospitalization (hazard ratio, 0.94; 95% confidence interval [CI], 0.79 to 1.12; P=0.52), nor in the rates of all hospitalizations (rate ratio, 1.01; 95% CI, 0.91 to 1.13), COPD exacerbations (rate ratio, 1.08; 95% CI, 0.98 to 1.19), and COPD-related hospitalizations (rate ratio, 0.99; 95% CI, 0.83 to 1.17). We found no consistent between-group differences in measures of quality of life, lung function, and the distance walked in 6 minutes. CONCLUSIONS In patients with stable COPD and resting or exercise-induced moderate desaturation, the prescription of long-term supplemental oxygen did not result in a longer time to death or first hospitalization than no long-term supplemental oxygen, nor did it provide sustained benefit with regard to any of the other measured outcomes. (Funded by the National Heart, Lung, and Blood Institute and the Centers for Medicare and Medicaid Services; LOTT ClinicalTrials.gov number, NCT00692198.)

Clinical Guideline Highlights for the Hospitalist: The GOLD and NICE Guidelines for the Management of COPD

“…In patients with moderate resting (89%-93%) or exercise-induced arterial desaturation (80%-90%), long-term oxygen does not improve outcomes (A, GOLD). 6 Recommendation 14. Consider longterm oxygan after a risk assessment of fall and burn risk.…”

Promoting Health Equity through De-Implementation Research

“…But a randomized controlled trial demonstrated that most patients with COPD (ie, all except a subset of the highest risk patients) derive no benefit from the oxygen-not in terms of survival, hospital admissions, or quality of life. 2 At the same time, oxygen significantly increases the risk of burns for patients; 3 it is costly to the patient; 4 and it is a burden that the patient literally has to carry that impairs their ability to socialize. 4 Other well-publicized examples of low-value care include hormone replacement therapy to prevent cardiovascular events among perimenopausal women; 5 antibiotics to treat viral upper-respiratory infections; and diagnostic imaging for simple lower-back pain.…”

Stigma and the in(visible) perspectives and expectations of home oxygen therapy among people with chronic breathlessness syndrome: A qualitative study

“…Oxygen is one of several strategies used to reduce breathlessness 6 and has been shown to increase the survival for people with Chronic Obstructive Pulmonary Disease (COPD) with severe hypoxaemia. However, oxygen's benefits are less clear for people with different diseases and for those people who are not hypoxemic, or only mildly so, and in some situations, may be no better than medical air 7,8 . Nevertheless, clinicians commonly prescribe oxygen in the palliative setting and there is evidence that non-clinical factors can influence prescribing patterns.…”