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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Aarhus University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen Therapy | Drug | Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 30 minutes after study treatment (supplemental oxygen) or placebo (room air) |
| Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 60 minutes after study treatment (supplemental oxygen) or placebo (room air) |
| Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 90 minutes after study treatment (supplemental oxygen) or placebo (room air) |
| Pulmonary artery systolic pressure (PASP) | PASP is measured on bedside echocardiogram | 180 minutes after study treatment (supplemental oxygen) or placebo (room air) |
| Measure | Description | Time Frame |
|---|---|---|
| Right ventricular to left ventricular ratio (RV/LV) | RV/LV ratio is measured on bedside echocardiogram | 30 minutes after study treatment (supplemental oxygen) or placebo (room air) |
| Right ventricular to left ventricular ratio (RV/LV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Kabrhel, MD, MPH | Contact | 617-726-7622 | ckabhrel@mgb.org | |
| Blair Alden Parry, CCRC, BA | Contact | 617-724-4758 | bparry@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Kabrhel, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39532350 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D054556 | Venous Thromboembolism |
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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Patient
| Non-rebreather mask | Device | Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting. |
|
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RV/LV ratio is measured on bedside echocardiogram
| 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 | 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 | 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. | 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. | 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. | 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. | 180 minutes after study treatment (supplemental oxygen) or placebo (room air) |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |