Supplemental Oxygen in Pulmonary Embolism (SO-PE)

This study is looking at how giving extra oxygen, called supplemental oxygen, helps adults who have a sudden blood clot in their lungs (acute pulmonary embolism or PE). Researchers want to see if breathing supplemental oxygen, delivered through a non-rebreather mask, can reduce the pressure in the lung arteries and improve how the right side of the heart works. You might be able to join if you are an adult (18 or older) with a recently confirmed PE, new or worsening symptoms, and your doctor has confirmed your heart's right side isn't working as well as it should, even if your oxygen levels are currently good. The main goal is to measure the pressure in your lung arteries at 30, 60, and 90 minutes after receiving either supplemental oxygen or regular room air. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 80 adult participants. It is a randomized, crossover trial where participants will receive both supplemental oxygen and room air at different times.
What's involved
You would receive supplemental oxygen or room air for periods of 30, 60, and 90 minutes, and then for 180 minutes. After each treatment change and at 180 minutes, you would have echocardiograms and blood draws.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements are taken at 30, 60, and 90 minutes after treatment, and then at 180 minutes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05891886

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Recruiting
EARLY_PHASE1Ages 18+Interventional
Massachusetts General Hospital
~80 participants
Updated 2025-06-15 on ClinicalTrials.gov
What's tested:Oxygen TherapyNon-rebreather mask

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pulmonary artery systolic pressure (PASP)
Measured over 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
+3 more outcomes measured
Pulmonary Embolism
Venous Thromboembolism
Metabolomics
Oxygen Inhalation Therapy

NCT05891886

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Christopher Kabrhel, MD, MPH · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

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

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
  • Pulmonary artery systolic pressure (PASP)30 minutes after study treatment (supplemental oxygen) or placebo (room air)

    PASP is measured on bedside echocardiogram

  • Pulmonary artery systolic pressure (PASP)60 minutes after study treatment (supplemental oxygen) or placebo (room air)

    PASP is measured on bedside echocardiogram

  • Pulmonary artery systolic pressure (PASP)90 minutes after study treatment (supplemental oxygen) or placebo (room air)

    PASP is measured on bedside echocardiogram

  • Pulmonary artery systolic pressure (PASP)180 minutes after study treatment (supplemental oxygen) or placebo (room air)

    PASP is measured on bedside echocardiogram