NCT05891886 Supplemental Oxygen in Pulmonary Embolism (SO-PE)
| NCT ID | NCT05891886 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Pulmonary Embolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2023-10-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Christopher Kabrhel, MD, MPH
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05891886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05891886 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05891886 currently recruiting?
Yes, NCT05891886 is actively recruiting participants. Contact the research team at ckabhrel@mgb.org for enrollment information.
Where is the NCT05891886 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05891886 clinical trial?
NCT05891886 is sponsored by Massachusetts General Hospital. The principal investigator is Christopher Kabrhel, MD, MPH at Massachusetts General Hospital. The trial plans to enroll 80 participants.