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Supplemental Oxygen

Oxygen Therapy for Pulmonary Embolism (SO-PE Trial)

Phase < 1

Recruiting

Led By Christopher Kabrhel, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed Pulmonary Embolism (PE) on computed tomography pulmonary angiography (CTPA) performed <24 hours prior to enrollment

Be older than 18 years old

Must not have

New onset arrhythmia

History of pulmonary hypertension, chronic obstructive pulmonary disease (COPD), hypoventilation syndrome, or congestive heart failure (CHF) with left ventricular ejection fraction <40%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 minutes after study treatment (supplemental oxygen) or placebo (room air)

Awards & highlights

No Placebo-Only Group

Summary

This trial studied how supplemental oxygen helps patients with acute PE by reducing right ventricular dysfunction (RVD) and pulmonary pressure (PA).

Who is the study for?

Adults over 18 with a recent pulmonary embolism confirmed by imaging, who can breathe on their own with oxygen saturation above 90%. Not for those unstable after the event, with new heart rhythm issues, pregnant, or on certain medications. Must be able to wear an oxygen mask.

What is being tested?

The trial is testing if supplemental oxygen given through a non-rebreather mask can help manage acute pulmonary embolism by reducing stress on the right side of the heart and lowering blood pressure in lung arteries due to low oxygen levels.

What are the potential side effects?

While receiving extra oxygen usually has minimal side effects, some may experience dry or bloody nose, morning headaches, tiredness during the day, and mild discomfort from wearing the mask.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with a lung clot by a CT scan less than 24 hours ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recently developed an irregular heartbeat.

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I have a history of lung or heart issues, including weak heart pumping.

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I am scheduled for a clot-dissolving treatment or clot removal surgery.

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I cannot wear a face mask due to medical reasons.

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My blood pressure and heart rate are stable.

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I am currently using medication to raise my blood pressure or devices to help my heart circulate blood.

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I use oxygen therapy regularly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 minutes after study treatment (supplemental oxygen) or placebo (room air)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 minutes after study treatment (supplemental oxygen) or placebo (room air)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 minutes after study treatment (supplemental oxygen) or placebo (room air) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pulmonary artery systolic pressure (PASP)

Secondary study objectives

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

Right ventricular to left ventricular ratio (RV/LV)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Supplemental oxygen delivered by facemaskExperimental Treatment2 Interventions

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.

Group II: Room air delivered by facemaskActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxygen Therapy

2019

N/A

~120

0 / 8Eligibility criteria met