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Long-Term Oxygen Therapy for 24 or 15 Hours per Day in Severe Hypoxemia
Magnus Ekström1, Anders Andersson1, Savvas Papadopoulos1
1From Respiratory Medicine, Allergology, and Palliative Medicine, Department of Clinical Sciences in Lund, Faculty of Medicine, Lund University, Lund (M.E., F.B.), the Department of Medicine, Blekinge Hospital, Karlskrona (M.E.), the COPD Center, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg (A.A.), and the Department of Respiratory Medicine and Allergology, Sahlgrenska University Hospital (S.P.), Gothenburg, Karlstad County Hospital, Karlstad (T.K.), Northern Älvsborg County Hospital, Trollhättan (B.P.), Linköping University Hospital, Linköping (O.K.), Falun Hospital, Falun (P.S.), the Department of Respiratory Medicine and Allergology, Faculty of Medicine, Karolinska University Hospital (M.R.), and Karolinska University Hospital Huddinge (R.H.), Stockholm, the Department of Medical Sciences, Respiratory, Allergy, and Sleep Research, Uppsala University (A.P., E.L., C.J.), and the Uppsala Clinical Research Center (N.H.), Uppsala, the Center for Research and Development, Gävle Hospital, Gävle (A.P.), the Department of Public Health and Clinical Medicine, Umeå University, Umeå (A.B.), Sundsvall-Härnösand County Hospital, Sundsvall (B.S.), and the Department of Respiratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro (J.S.) - all in Sweden; the Institute for Breathing and Sleep and the Department of Respiratory and Sleep Medicine, Austin Health, Melbourne, VIC (C.F.M.), and the Graduate School of Medicine, Faculty of Science, Medicine, and Health, University of Wollongong, Wollongong, NSW (D.C.C.) - both in Australia.
Background:
Long-term oxygen supplementation for at least 15 hours per day prolongs survival among patients with severe hypoxemia. On the basis of a nonrandomized comparison, long-term oxygen therapy has been recommended to be used for 24 hours per day, a more burdensome regimen.
Methods:
To test the hypothesis that long-term oxygen therapy used for 24 hours per day does not result in a lower risk of hospitalization or death at 1 year than therapy for 15 hours per day, we conducted a multicenter, registry-based, randomized, controlled trial involving patients who were starting oxygen therapy for chronic, severe hypoxemia at rest. The patients were randomly assigned to receive long-term oxygen therapy for 24 or 15 hours per day. The primary outcome, assessed in a time-to-event analysis, was a composite of hospitalization or death from any cause within 1 year. Secondary outcomes included the individual components of the primary outcome assessed at 3 and 12 months.
Results:
Between May 18, 2018, and April 4, 2022, a total of 241 patients were randomly assigned to receive long-term oxygen therapy for 24 hours per day (117 patients) or 15 hours per day (124 patients). No patient was lost to follow-up. At 12 months, the median patient-reported daily duration of oxygen therapy was 24.0 hours (interquartile range, 21.0 to 24.0) in the 24-hour group and 15.0 hours (interquartile range, 15.0 to 16.0) in the 15-hour group. The risk of hospitalization or death within 1 year in the 24-hour group was not lower than that in the 15-hour group (mean rate, 124.7 and 124.5 events per 100 person-years, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.72 to 1.36; 90% CI, 0.76 to 1.29; P = 0.007 for nonsuperiority). The groups did not differ substantially in the incidence of hospitalization for any cause, death from any cause, or adverse events.
Conclusions:
Among patients with severe hypoxemia, long-term oxygen therapy used for 24 hours per day did not result in a lower risk of hospitalization or death within 1 year than therapy for 15 hours per day. (Funded by the Crafoord Foundation and others; REDOX ClinicalTrials.gov number, NCT03441204.).
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