Recruiting
Early Phase 1

SO-PE

Sponsor:

Massachusetts General Hospital

Code:

NCT05891886

Conditions

Pulmonary Embolism

Venous Thromboembolism

Metabolomics

Oxygen Inhalation Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxygen Therapy

Non-rebreather mask

Study Details

Brief 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.

Conditions

Pulmonary Embolism

Venous Thromboembolism

Metabolomics

Oxygen Inhalation Therapy

Study ID

NCT05891886

Start date

Oct 1, 2023

Status verified date

Jun, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Oxygen Therapy

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

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.

Primary outcome measure

  • Pulmonary artery systolic pressure (PASP) [ Time Frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air) ]
  • Pulmonary artery systolic pressure (PASP) [ Time Frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air) ]
  • Pulmonary artery systolic pressure (PASP) [ Time Frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air) ]
  • Pulmonary artery systolic pressure (PASP) [ Time Frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air) ]

Central Contacts and Locations

Central contacts

Christopher Kabrhel, MD, MPH

617-726-7622ckabhrel@mgb.org

Blair Alden Parry, CCRC, BA

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Blair Alden Parry, CCRC, BA

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

Principal Investigator:

Christopher Kabrhel, MD, MPH

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 15, 2025

Last verified

Jun, 2025

Keywords

  • Pulmonary Embolism
  • PE
  • Right ventricular dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-06-15.