Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891886

Collaborator

University of Aarhus (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism Venous Thromboembolism Metabolomics Oxygen Inhalation Therapy	Drug: Oxygen Therapy Device: Non-rebreather mask	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supplemental oxygen delivered by facemask Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.	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. Other Names: NRM (Non-rebreather mask)
Active Comparator: Room air delivered by facemask Patients with acute PE will be randomized to breathing room air by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.	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. Other Names: NRM (Non-rebreather mask)

Arm

Intervention/Treatment

Experimental: Supplemental oxygen delivered by facemask

Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.

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.

Other Names:

NRM (Non-rebreather mask)

Active Comparator: Room air delivered by facemask

Patients with acute PE will be randomized to breathing room air by non-rebreather face mask first. Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.

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.

Other Names:

NRM (Non-rebreather mask)

Outcome Measures

Primary Outcome Measures

Pulmonary artery systolic pressure (PASP) [30 minutes after study treatment (supplemental oxygen) or placebo (room air)]
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP) [60 minutes after study treatment (supplemental oxygen) or placebo (room air)]
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP) [90 minutes after study treatment (supplemental oxygen) or placebo (room air)]
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP) [180 minutes after study treatment (supplemental oxygen) or placebo (room air)]
PASP is measured on bedside echocardiogram

Secondary Outcome Measures

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
Right ventricular to left ventricular ratio (RV/LV) [60 minutes after study treatment (supplemental oxygen) or placebo (room air)]
RV/LV ratio is measured on bedside echocardiogram
Right ventricular to left ventricular ratio (RV/LV) [90 minutes after study treatment (supplemental oxygen) or placebo (room air)]
RV/LV ratio is measured on bedside echocardiogram
Right ventricular to left ventricular ratio (RV/LV) [180 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.
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays [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.
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays [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.
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

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

Investigators

Principal Investigator: Christopher Kabrhel, MD, MPH, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher Kabrhel MD MPH, Professor of Emergency Medicine; Attending Physician, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05891886

Other Study ID Numbers:

2023P000252

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Christopher Kabrhel MD MPH, Professor of Emergency Medicine; Attending Physician, Massachusetts General Hospital

Pulmonary Embolism, PE, RVD

Additional relevant MeSH terms:

Pulmonary Embolism

Embolism

Thromboembolism

Venous Thromboembolism

Study Results

No Results Posted as of Jun 7, 2023