Pulmonary EmbolismEarly Phase 1SO-PENCT05891886
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
A Early Phase 1 study testing Oxygen Therapy and Non-rebreather mask in people with Pulmonary Embolism and Venous Thromboembolism, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism, Metabolomics
- What is being tested?
- Oxygen Therapy and Non-rebreather mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Blair Alden Parry, CCRC, BA, 617-724-4758, bparry@mgh.harvard.edu
Christopher Kabrhel, MD, MPH
About this study
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.
Read the detailed description
In the Emergency Department (ED), investigators will perform a randomized, crossover trial of adult patients with acute PE.
Study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. Therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes.
After each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (RVD) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.
- Being tested
- Oxygen Therapy, Non-rebreather mask
- Keywords
- Pulmonary Embolism, PE, Right ventricular dysfunction
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen TherapyDrug
Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
Non-rebreather maskDevice
Also called NRM (Non-rebreather mask)
Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen delivered by facemask | Experimental | 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. Receives: Drug: Oxygen Therapy; Device: Non-rebreather mask |
| Room air delivered by facemask | Active comparator | 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. Receives: Device: Non-rebreather mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Measured: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Measured: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Measured: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Measured: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary outcomes (8)
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Measured: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Measured: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Measured: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Measured: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Measured: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Measured: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Measured: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Measured: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Oct 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Kabrhel MD MPH, Massachusetts General Hospital
- Investigators
- Christopher Kabrhel, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891886
- Sponsor's protocol ID
- 2023P000252
- Acronym
- SO-PE
- Status last verified
- Jun 2025
- First submitted
- 4 May 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers. The results of this study will be published in scientific journals and presented at national/international scientific meetings.
Publications
Lyhne MD, Liteplo AS, Zeleznik OA, Dudzinski DM, Andersen A, Shokoohi H, Al Jalbout N, Eke OF, Morone CC, Huang CK, Heyne TF, Kalra MK, Kabrhel C. Supplemental oxygen for pulmonary embolism (SO-PE): study protocol for a mechanistic, randomised, blinded, cross-over study. BMJ Open. 2024 Nov 12;14(11):e091567. doi: 10.1136/bmjopen-2024-091567.
PubMed 39532350
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Oxygen in Pulmonary Embolism (SO-PE)
- ClinicalTrials.gov ID
- NCT05891886
- Acronym / sponsor ID
- SO-PE / 2023P000252
- Keywords
- Pulmonary Embolism, PE, Right ventricular dysfunction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Aarhus University Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the Emergency Department (ED), investigators will perform a randomized, crossover trial of adult patients with acute PE.
Study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. Therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes.
After each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (RVD) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen delivered by facemask | Experimental | Drug: Oxygen Therapy, Device: Non-rebreather maskPatients 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. |
| Room air delivered by facemask | Active comparator | Device: Non-rebreather maskPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen TherapyStudy subjects will be asked to breathe supplemental, or extra, oxygen during several time periods. | Drug | Supplemental oxygen delivered by facemask |
| Non-rebreather maskAlso: NRM (Non-rebreather mask)Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting. | Device | Room air delivered by facemask, Supplemental oxygen delivered by facemask |
Primary outcome
Pulmonary artery systolic pressure (PASP)
Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP)
Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP)
Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP)
Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
8 secondary outcomes
Right ventricular to left ventricular ratio (RV/LV)
Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Right ventricular to left ventricular ratio (RV/LV)
Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Right ventricular to left ventricular ratio (RV/LV)
Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Right ventricular to left ventricular ratio (RV/LV)
Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 39532350Lyhne MD, Liteplo AS, Zeleznik OA, Dudzinski DM, Andersen A, Shokoohi H, Al Jalbout N, Eke OF, Morone CC, Huang CK, Heyne TF, Kalra MK, Kabrhel C. Supplemental oxygen for pulmonary embolism (SO-PE): study protocol for a mechanistic, randomised, blinded, cross-over study. BMJ Open. 2024 Nov 12;14(11):e091567. doi: 10.1136/bmjopen-2024-091567.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers. The results of this study will be published in scientific journals and presented at national/international scientific meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Kabrhel, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxygen Therapy and Non-rebreather mask in people with Pulmonary Embolism and Venous Thromboembolism, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Kabrhel, MD, MPH (617-726-7622, ckabhrel@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary artery systolic pressure (PASP) (time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.