Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Last updated: October 17, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Venous Thrombosis

Vascular Diseases

Pulmonary Embolism

Treatment

Non-rebreather mask

Oxygen Therapy

Clinical Study ID

NCT05891886
2023P000252
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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 EmergencyDepartment (ED)
  • New onset arrhythmia
  • History of pulmonary hypertension, chronic obstructive pulmonary disease (COPD),hypoventilation syndrome, or congestive heart failure (CHF) with left ventricularejection 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

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Non-rebreather mask
Phase: 1
Study Start date:
October 01, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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