Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Mass General Brigham

Status and phase: Enrolling; Early Phase 1

Conditions: Venous Thromboembolism; Pulmonary Embolism; Metabolomics; Oxygen Inhalation Therapy

Treatments: Device: Non-rebreather mask; Drug: Oxygen Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05891886

2023P000252

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Supplemental oxygen delivered by facemask

Experimental group

Description:

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.

Treatment:

Drug: Oxygen Therapy

Device: Non-rebreather mask

Room air delivered by facemask

Active Comparator group

Description:

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.

Treatment:

Device: Non-rebreather mask