← Back to Clinical Trials
Recruiting EARLY_Phase 1 NCT05891886

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

◆ AI Clinical Summary

This study examines whether giving extra oxygen to patients with acute pulmonary embolism (a blood clot in the lungs) can help improve heart function. Researchers believe oxygen may reduce pressure in the lungs and help the right side of the heart work better during this serious condition.

Key Objective: The trial tests whether supplemental oxygen can reduce strain on the heart and lower lung pressure in patients with acute pulmonary embolism.

Who to Consider: Patients recently diagnosed with acute pulmonary embolism who are experiencing right ventricular dysfunction should consider enrolling.

Trial Parameters

Condition Pulmonary Embolism
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-01
Completion 2027-06-30
Interventions
Oxygen TherapyNon-rebreather mask

Brief 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.

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

Related Trials