Oxygen Therapy in Patients With Intermediate-Risk Acute Pulmonary Embolism: A Randomized Trial

Chest. 2024 Mar;165(3):673-681. doi: 10.1016/j.chest.2023.09.007. Epub 2023 Sep 16.


Background: The effect of supplemental oxygen therapy in patients with intermediate-risk pulmonary embolism (PE) who do not have hypoxemia at baseline is uncertain.

Research question: Does supplemental oxygen improve echocardiographic parameters in nonhypoxemic patients with intermediate-risk PE?

Study design and methods: This pilot trial randomly assigned nonhypoxemic patients with stable PE and echocardiographic right ventricle (RV) enlargement to receive anticoagulation plus supplemental oxygen for the first 48 h vs anticoagulation alone. The primary outcome was normal echocardiographic RV size 48 h after randomization. Secondary efficacy outcomes were the numerical change in the RV to left ventricle (LV) diameter ratio measured 48 h and 7 days after randomization with respect to the baseline ratio measured at inclusion.

Results: The study was stopped prematurely because of the COVID-19 pandemic after recruiting 70 patients (mean ± SD age, 67.3 ± 16.1 years; 36 female [51.4%]) with primary outcome data. Forty-eight h after randomization, normalization of the RV size occurred in 14 of the 33 patients (42.4%) assigned to oxygen and in eight of the 37 patients (21.6%) assigned to ambient air (P = .08). In the oxygen group, the mean RV to LV ratio was reduced from 1.28 ± 0.28 at baseline to 1.01 ± 0.16 at 48 h (P < .001); in the ambient air group, mean RV to LV ratios were 1.21 ± 0.18 at baseline and 1.08 ± 0.19 at 48 h (P < .01). At 90 days, one major bleeding event and one death (both in the ambient air group) had occurred.

Interpretation: In analyses limited by a small number of enrollees, compared with ambient air, supplemental oxygen did not significantly increase the proportion of patients with nonhypoxemic intermediate-risk PE whose RV to LV ratio normalized after 48 h of treatment. This pilot trial showed improvement in some ancillary efficacy outcomes and provides support for a definitive clinical outcomes trial.

Trial registry: ClinicalTrials.gov; No.: NCT04003116; URL: www.

Clinicaltrials: gov.

Keywords: oxygen; pulmonary embolism; treatment.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Aged
  • Aged, 80 and over
  • Anticoagulants / therapeutic use
  • COVID-19*
  • Female
  • Humans
  • Middle Aged
  • Oxygen / therapeutic use
  • Pandemics
  • Pulmonary Embolism* / drug therapy
  • Treatment Outcome


  • Anticoagulants
  • Oxygen

Associated data

  • ClinicalTrials.gov/NCT04003116