NCT05891886

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In the Emergency Department (ED), investigators will perform a randomized, crossover trial of adult patients with acute PE. Study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. Therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes. After each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (RVD) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.

Conditions

• Pulmonary Embolism
• Venous Thromboembolism
• Metabolomics
• Oxygen Inhalation Therapy

Interventions

Type	Name	Description
DRUG	Oxygen Therapy	Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
DEVICE	Non-rebreather mask	Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.

Timeline

• Start date: 2023-10-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2023-06-07
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study