• Deisy Barrios, Diego Durán, Carmen Rodríguez, Jorge Moisés, Ana Retegui, José Luis Lobo, Raquel López, Leyre Chasco, Luis Jara-Palomares, Alfonso Muriel, Remedios Otero-Candelera, Pedro Ruiz-Artacho, Manuel Monreal, Behnood Bikdeli, David Jiménez, and Air vs Oxygen for Intermediate-Risk Pulmonary Embolism Investigators.
• Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.
• Chest. 2024 Mar 1; 165 (3): 673681673-681.

BackgroundThe effect of supplemental oxygen therapy in patients with intermediate-risk pulmonary embolism (PE) who do not have hypoxemia at baseline is uncertain.Research QuestionDoes supplemental oxygen improve echocardiographic parameters in nonhypoxemic patients with intermediate-risk PE?Study Design And MethodsThis 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.ResultsThe 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.InterpretationIn 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 RegistryClinicalTrials.gov; No.: NCT04003116; URL: www.Clinicaltrialsgov.Copyright © 2023 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

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