Supplemental Oxygen in Pulmonary Embolism (SO-PE)

• Status: Not yet recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Aarhus

Criteria

Inclusion Criteria:

• Adults ≥18 years old

• Confirmed Pulmonary Embolism (PE) on computed tomography pulmonary angiography (CTPA) performed <24 hours prior to enrollment

• Symptom duration <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 at any time in the Emergency Department (ED)

• New onset arrhythmia

• History of pulmonary hypertension, chronic obstructive pulmonary disease (COPD), hypoventilation syndrome, or congestive heart failure (CHF) with left ventricular ejection fraction <40%

• Known pregnancy

• Use of chronic oxygen therapy at baseline

• Vasodilator medication used in the past 24 hours

• Symptom onset ≥72 hours

• Inability to wear a face mask

• Technically inadequate baseline echocardiogram

• Temperature >39° C

• Positive test for Covid-19 or influenza within the previous 10 days