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Supplemental Oxygen in Pulmonary Embolism (SO-PE)
RECRUITINGEarly 1Sponsored by Massachusetts General Hospital
Actively Recruiting
PhaseEarly 1
SponsorMassachusetts General Hospital
Started2023-10-01
Est. completion2027-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05891886
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions5
Heart DiseaseMetabolomicsOxygen Inhalation TherapyPulmonary EmbolismVenous Thromboembolism
Locations1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
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Actively Recruiting
PhaseEarly 1
SponsorMassachusetts General Hospital
Started2023-10-01
Est. completion2027-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05891886