The rationale, design, and methods of a trial to evaluate the efficacy and safety of oxygen therapy in patients with intermediate-risk acute pulmonary embolism.

Autores de IIS La Fe

• María Cristina Rodríguez Varela

  Autor

• Jose Luis Lobo Beristain

  Autor

• Raquel López Reyes

  Autor

Participantes ajenos a IIS La Fe

• Duran, Diego
• Barrios, Deisy
• Moises, Jorge
• Retegui, Ana
• Chasco, Leyre
• Jara-Palomares, Luis
• Monreal, Manuel
• Bikdeli, Behnood
• Jimenez, David
• AIR Investigators

Grupos

• Endocrinología Reproductiva e Infertilidad

  Leader

  José Remohí Giménez

• Neumología

  

  Leader

  Miguel Ángel Martínez García

Abstract

INTRODUCTION: In patients with intermediate-risk pulmonary embolism (PE), reversal of hypoxic vasoconstriction could constitute a target for treatment that protects the right ventricular (RV) function until endogenous fibrinolysis occurs. The Air versus oxygen for Intermediate-Risk pulmonary embolism (AIR) trial aims to assess the effect of oxygen therapy in patients with intermediate-risk acute PE who do not have hypoxemia at baseline. METHODS AND ANALYSES: AIR is a prospective, multicenter, randomized, open-label, parallel-group, proof-of-concept trial. A total of 90 patients hospitalized with intermediate-risk PE and an oxygen saturation of 90% or higher at baseline will be randomized in a 1:1 fashion to receive supplemental oxygen or ambient air. The primary outcome is a RV/LV diameter ratio equal or less than 1.0 on echocardiography measured 48 hours after the start of treatment. Secondary efficacy outcomes are the numerical change in the ratio of the RV to the LV diameter measured 48 hours and 7 days after the start of treatment, with respect to the baseline ratio measured at randomization. Clinical adverse events will be also collected. RESULTS: Enrollment started in July 2019 and is expected to proceed until 2022. Median age of the first 50 patients was 74 years (interquartile range, 61-81), and 50% were female. CONCLUSIONS: This multicenter trial will provide information about the value of supplemental oxygen in patients with intermediate-risk acute PE who do not have hypoxemia at baseline. The results will contribute to research that may assist patients with intermediate-risk PE in the future.

Copyright © 2022. Published by Elsevier Inc.

Keywords

• Pulmonary embolism; oxygen; treatment