Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 26, 2023

Keywords

ClinConnect Summary

The SO-PE trial is a clinical study looking at how supplemental oxygen can help patients who have a condition called acute pulmonary embolism (PE). This condition occurs when a blood clot blocks the blood vessels in the lungs, which can make it hard for the heart to pump blood effectively. The study aims to understand if providing extra oxygen can improve heart function in these patients by relieving pressure and improving blood flow in the lungs.

To participate in this trial, you need to be an adult over 18 years old who has been diagnosed with pulmonary embolism within the last 24 hours and has experienced symptoms for less than 72 hours. You should also be able to breathe room air with an oxygen level of at least 90%. However, if you have certain conditions like severe heart problems, are pregnant, or have recently tested positive for COVID-19 or the flu, you may not be eligible. If you join the trial, you will receive supplemental oxygen while closely monitored by healthcare professionals to see how it affects your heart and lung function. This study is currently recruiting participants, and your involvement could help improve treatment for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• 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