Supplemental Oxygen in Pulmonary Embolism (SO-PE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxygen Therapy, Non-rebreather mask.
- Who it may be relevant to
- Registry conditions: Pulmonary Embolism, Venous Thromboembolism, Metabolomics, Oxygen Inhalation Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Oxygen Therapy
Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods. - Device 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.
Primary outcome measures
- Pulmonary artery systolic pressure (PASP) [Time frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)]
- Pulmonary artery systolic pressure (PASP) [Time frame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)]
- Pulmonary artery systolic pressure (PASP) [Time frame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)]
- Pulmonary artery systolic pressure (PASP) [Time frame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)]
Secondary outcome measures (8)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
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. PMID 39532350
Identifiers
NCT: NCT05891886 · 2023P000252