Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Purpose

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

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Single (Participant)
Masking Description
Patient

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Supplemental oxygen delivered by facemask 		Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.
  • 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.
    Other names:
    • NRM (Non-rebreather mask)
Active Comparator
Room air delivered by facemask 		Patients with acute PE will be randomized to breathing room air by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.
  • 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.
    Other names:
    • NRM (Non-rebreather mask)

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Blair Alden Parry, CCRC, BA
617-724-4758
bparry@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Christopher Kabrhel, MD, MPH
617-726-7622
ckabhrel@mgb.org

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.