Clinical trial NCT05891886: Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Official title: Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pulmonary Embolism
Venous Thromboembolism
Metabolomics
Oxygen Inhalation Therapy
Keywords: Pulmonary Embolism
PE
Right ventricular dysfunction
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Aarhus University Hospital
First posted: 2023-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Pulmonary artery systolic pressure (PASP)
timeFrame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Pulmonary artery systolic pressure (PASP)
timeFrame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Pulmonary artery systolic pressure (PASP)
timeFrame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Pulmonary artery systolic pressure (PASP)
timeFrame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary outcomes:
measure: Right ventricular to left ventricular ratio (RV/LV)
timeFrame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Right ventricular to left ventricular ratio (RV/LV)
timeFrame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Right ventricular to left ventricular ratio (RV/LV)
timeFrame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Right ventricular to left ventricular ratio (RV/LV)
timeFrame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
timeFrame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
timeFrame: 60 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
timeFrame: 90 minutes after study treatment (supplemental oxygen) or placebo (room air)
measure: Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
timeFrame: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher Kabrhel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: