Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Location contact
Blair Alden Parry, CCRC, BA
CONTACT
Christopher Kabrhel, MD, MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05891886
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Boston, Massachusetts, 02114, United States
Location status: Recruiting
Blair Alden Parry, CCRC, BA
CONTACT
Christopher Kabrhel, MD, MPH
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: NRM (Non-rebreather mask)
Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
RV/LV ratio is measured on bedside echocardiogram
Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
RV/LV ratio is measured on bedside echocardiogram
Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
RV/LV ratio is measured on bedside echocardiogram
Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
RV/LV ratio is measured on bedside echocardiogram
Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
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)
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)
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)
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Contact information is provided by the study sponsor or research team.
Blair Alden Parry, CCRC, BA
CONTACT
Christopher Kabrhel, MD, MPH
CONTACT
Massachusetts General Hospital
Other
Acronym: SO-PE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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