Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Early Phase 1RecruitingNCT05891886

Massachusetts General Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Pulmonary Embolism Venous Thromboembolism Metabolomics Oxygen Inhalation Therapy

Interventions

Oxygen TherapyDRUG

Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.

Non-rebreather maskDEVICE

Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Pulmonary artery systolic pressure (PASP)

PASP is measured on bedside echocardiogram

Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)

Pulmonary artery systolic pressure (PASP)

PASP is measured on bedside echocardiogram

Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)

Pulmonary artery systolic pressure (PASP)

PASP is measured on bedside echocardiogram

Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)

Pulmonary artery systolic pressure (PASP)

PASP is measured on bedside echocardiogram

Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)

Secondary Outcomes

Right ventricular to left ventricular ratio (RV/LV)

RV/LV ratio is measured on bedside echocardiogram

Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)

Right ventricular to left ventricular ratio (RV/LV)

RV/LV ratio is measured on bedside echocardiogram

Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)

Right ventricular to left ventricular ratio (RV/LV)

RV/LV ratio is measured on bedside echocardiogram

Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)

Central Contacts

Christopher Kabrhel, MD, MPH

CONTACT

617-726-7622 ckabhrel@mgb.org

Blair Alden Parry, CCRC, BA

CONTACT

617-724-4758 bparry@mgh.harvard.edu

Data from ClinicalTrials.gov

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