Using supplemental oxygen to treat pulmonary embolism
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
EARLY_PHASE1 · Massachusetts General Hospital · NCT05891886
This study is testing if giving extra oxygen to people with acute pulmonary embolism can help their heart function better and improve their overall health.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05891886 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of supplemental oxygen on patients with acute pulmonary embolism (PE) and its potential to alleviate right ventricular dysfunction (RVD). In a randomized, crossover design, adult patients will receive either supplemental oxygen or room air, with therapy alternated at specified intervals. Echocardiograms and blood samples will be collected to assess the impact of oxygen therapy on RVD and to analyze metabolic changes. The goal is to understand how oxygen therapy may improve patient outcomes in acute PE.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed acute pulmonary embolism and right ventricular dysfunction.
Not a fit: Patients with hemodynamic instability, severe respiratory conditions, or those requiring advanced interventions like thrombolytics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment strategies for patients suffering from acute pulmonary embolism.
How similar studies have performed: While the specific approach of using supplemental oxygen in this context is novel, related studies on oxygen therapy have shown promising results in other respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Christopher Kabrhel, MD, MPH — Massachusetts General Hospital
- Study coordinator: Christopher Kabrhel, MD, MPH
- Email: ckabhrel@mgb.org
- Phone: 617-726-7622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Embolism, Venous Thromboembolism, Metabolomics, Oxygen Inhalation Therapy, PE, Right ventricular dysfunction