Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Pulmonary Embolism Clinical Trial

— SO-PE  

Official title:

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891886
• Other study ID #: 2023P000252
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Christopher Kabrhel, MD, MPH
• Phone: 617-726-7622
• Email: ckabhrel[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults =18 years old

• Confirmed Pulmonary Embolism (PE) on computed tomography pulmonary angiography (CTPA) performed <24 hours prior to enrollment

• Symptom duration <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 at any time in the Emergency Department (ED)

• New onset arrhythmia

• History of pulmonary hypertension, chronic obstructive pulmonary disease (COPD), hypoventilation syndrome, or congestive heart failure (CHF) with left ventricular ejection fraction <40%

• Known pregnancy

• Use of chronic oxygen therapy at baseline

• Vasodilator medication used in the past 24 hours

• Symptom onset =72 hours

• Inability to wear a face mask

• Technically inadequate baseline echocardiogram

• Temperature >39° C

• Positive test for Covid-19 or influenza within the previous 10 days

Related Conditions & MeSH terms

• Embolism
• Metabolomics
• Oxygen Inhalation Therapy
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI), University of Aarhus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary artery systolic pressure (PASP)	PASP is measured on bedside echocardiogram	30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Primary	Pulmonary artery systolic pressure (PASP)	PASP is measured on bedside echocardiogram	60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Primary	Pulmonary artery systolic pressure (PASP)	PASP is measured on bedside echocardiogram	90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Primary	Pulmonary artery systolic pressure (PASP)	PASP is measured on bedside echocardiogram	180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	Right ventricular to left ventricular ratio (RV/LV)	RV/LV ratio is measured on bedside echocardiogram	30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	Right ventricular to left ventricular ratio (RV/LV)	RV/LV ratio is measured on bedside echocardiogram	60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	Right ventricular to left ventricular ratio (RV/LV)	RV/LV ratio is measured on bedside echocardiogram	90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	Right ventricular to left ventricular ratio (RV/LV)	RV/LV ratio is measured on bedside echocardiogram	180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	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.	30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	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.	60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	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.	90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary	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.	180 minutes after study treatment (supplemental oxygen) or placebo (room air)