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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Awards & highlights

SO-PE Trial 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.Check my eligibility
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.See study design
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.

SO-PE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with a lung clot by a CT scan less than 24 hours ago.

SO-PE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pulmonary artery systolic pressure (PASP)
Secondary outcome measures
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Right ventricular to left ventricular ratio (RV/LV)

SO-PE 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
2021
N/A
~10

Find a Location

Who is running the clinical trial?

University of AarhusOTHER
1,357 Previous Clinical Trials
14,420,742 Total Patients Enrolled
7 Trials studying Pulmonary Embolism
665 Patients Enrolled for Pulmonary Embolism
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,044 Total Patients Enrolled
19 Trials studying Pulmonary Embolism
149,675 Patients Enrolled for Pulmonary Embolism
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,561 Total Patients Enrolled
4 Trials studying Pulmonary Embolism
744 Patients Enrolled for Pulmonary Embolism

Media Library

Oxygen Therapy (Supplemental Oxygen) Clinical Trial Eligibility Overview. Trial Name: NCT05891886 — Phase < 1
Pulmonary Embolism Research Study Groups: Supplemental oxygen delivered by facemask, Room air delivered by facemask
Pulmonary Embolism Clinical Trial 2023: Oxygen Therapy Highlights & Side Effects. Trial Name: NCT05891886 — Phase < 1
Oxygen Therapy (Supplemental Oxygen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05891886 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could prospective participants access this research initiative?

"According to the information on clinicaltrials.gov, this particular trial is not accepting new participants at present. It was initially posted on July 1st 2023 and its most recent update occurred on May 26th 2023. Although it no longer seeks enrolment, 153 other trials are currently enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Christopher Kabrhel MD MPH 2023. "Supplemental Oxygen in Pulmonary Embolism (SO-PE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05891886.
All > Pulmonary Embolism
~53 spots leftby Jun 2027
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