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Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Recruiting
18 years and older
All
Phase N/A

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Overview

A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE).

Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.

Description

In the Emergency Department (ED), investigators will perform a randomized, crossover trial of adult patients with acute PE.

Study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. Therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes.

After each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (RVD) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.

Eligibility

Inclusion Criteria:

  • Adults ≥18 years old
  • Confirmed Pulmonary Embolism (PE) on imaging <24 hours prior to enrollment
  • New symptom onset and / or worsening symptoms <72 hours
  • Confirmation of right ventricular dysfunction (RVD) by clinician
  • Oxygen saturation ≥90% while breathing room air

Exclusion Criteria:

  • Hemodynamic instability
  • Use of vasopressors or mechanical circulatory support
  • Planned use of thrombolytics or plan for embolectomy
  • Oxygen saturation <90% while breathing room air
  • New onset arrhythmia
  • History of pulmonary hypertension, severe chronic obstructive pulmonary disease (COPD) requiring home oxygen or chronic steroid use, hypoventilation syndrome requiring continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or congestive heart failure (CHF) with LV ejection fraction < 40% or chronic oxygen therapy
  • Known pregnancy
  • Vasodilator medication used in the past 24 hours
  • Symptom onset ≥72 hours
  • Inability to wear a face mask
  • Inability to obtain adequate baseline echocardiogram

Study details
    Pulmonary Embolism
    Venous Thromboembolism
    Metabolomics
    Oxygen Inhalation Therapy

NCT05891886

Massachusetts General Hospital

23 June 2025

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