Pulmonary Embolism Clinical Trial
— SO-PEOfficial title:
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Heart, Lung, and Blood Institute (NHLBI), University of Aarhus |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 30 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Primary | Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 60 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Primary | Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 90 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Primary | Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 180 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Right ventricular to left ventricular ratio (RV/LV) | RV/LV ratio is measured on bedside echocardiogram | 30 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Right ventricular to left ventricular ratio (RV/LV) | RV/LV ratio is measured on bedside echocardiogram | 60 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Right ventricular to left ventricular ratio (RV/LV) | RV/LV ratio is measured on bedside echocardiogram | 90 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Right ventricular to left ventricular ratio (RV/LV) | RV/LV ratio is measured on bedside echocardiogram | 180 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays | Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE. | 30 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays | Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE. | 60 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays | Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE. | 90 minutes after study treatment (supplemental oxygen) or placebo (room air) | |
Secondary | Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays | Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE. | 180 minutes after study treatment (supplemental oxygen) or placebo (room air) |
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