Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Massachusetts General Hospital
80 participants
Oct 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria11
- 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
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Interventions
Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05891886