Metabolomics, Oxygen Inhalation Therapy, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Pulmonary Embolism, PE, Right ventricular dysfunction
Brief 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 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.
Interventions
DRUGOxygen Therapy
Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
DEVICENon-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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Aarhus University Hospital
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Patient
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary artery systolic pressure (PASP) | 30 minutes after study treatment (supplemental oxygen) or placebo (room air) | PASP is measured on bedside echocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Right ventricular to left ventricular ratio (RV/LV) | 30 minutes after study treatment (supplemental oxygen) or placebo (room air) | RV/LV ratio is measured on bedside echocardiogram |
| Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays | 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. |
Countries
United States
Contacts
Primary ContactChristopher Kabrhel, MD, MPH
Backup ContactBlair Alden Parry, CCRC, BA
Outcome results
None listed