An Early Phase 1 interventional study of Oxygen Therapy and Non-rebreather mask in Pulmonary Embolism, Venous Thromboembolism and Metabolomics, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other
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.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 80 is below the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Oxygen Therapy · Device: Non-rebreather mask
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.
Device: Non-rebreather mask
Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.
Also known as: NRM (Non-rebreather mask)
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame: 180 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
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
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
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
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
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
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Plan to share: 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.
No publications or documents are linked to this record.
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