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NCT Number: NCT05891886

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Blair Alden Parry, CCRC, BA

CONTACT

[email protected]

617-724-4758

Christopher Kabrhel, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen Therapy

Drug

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

Non-Rebreather mask

Device

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)

Primary outcomes

  1. Pulmonary artery systolic pressure (PASP)

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

    PASP is measured on bedside echocardiogram

  2. Pulmonary artery systolic pressure (PASP)

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

    PASP is measured on bedside echocardiogram

  3. Pulmonary artery systolic pressure (PASP)

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

    PASP is measured on bedside echocardiogram

  4. Pulmonary artery systolic pressure (PASP)

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

    PASP is measured on bedside echocardiogram

Secondary outcomes

  1. Right ventricular to left ventricular ratio (RV/LV)

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

    RV/LV ratio is measured on bedside echocardiogram

  2. Right ventricular to left ventricular ratio (RV/LV)

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

    RV/LV ratio is measured on bedside echocardiogram

  3. Right ventricular to left ventricular ratio (RV/LV)

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

    RV/LV ratio is measured on bedside echocardiogram

  4. Right ventricular to left ventricular ratio (RV/LV)

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

    RV/LV ratio is measured on bedside echocardiogram

  5. Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays

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

    Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.

  6. Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays

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

    Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.

  7. Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays

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

    Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.

  8. Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays

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

    Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.

Study contacts

Contact information is provided by the study sponsor or research team.

Blair Alden Parry, CCRC, BA

CONTACT

[email protected]

617-724-4758

Christopher Kabrhel, MD, MPH

CONTACT

[email protected]

617-726-7622

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Aarhus University Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: SO-PE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 7, 2023
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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