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Supplemental Oxygen in Pulmonary Embolism (SO-PE)

NCT05891886 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Aarhus University Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Christopher Kabrhel, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05891886 on ClinicalTrials.gov