Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
Qualifiers
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
Disqualifiers
Hemodynamic instability
Use of vasopressors or mechanical circulatory support
Planned use of thrombolytics or plan for embolectomy
Oxygen saturation <90% while breathing room air
Trial design
Treatments tested in this trial
- Oxygen Therapy
- Non-rebreather mask
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov