Supplemental Oxygen in Pulmonary Embolism (SO-PE)

NCT ID: NCT05891886

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2027-06-30

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.

Conditions

Pulmonary Embolism; Venous Thromboembolism; Metabolomics; Oxygen Inhalation Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxygen Therapy

Intervention Type: DRUG

Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.

Non-rebreather mask

Intervention Type: DEVICE

Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.

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.

Group Type: ACTIVE_COMPARATOR

Non-rebreather mask

Intervention Type: DEVICE

Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.

Interventions

Oxygen Therapy

Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

NRM (Non-rebreather mask)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christopher Kabrhel MD MPH

Professor of Emergency Medicine; Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Kabrhel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christopher Kabrhel, MD, MPH

Role: CONTACT

ckabhrel@mgb.org

617-726-7622

Blair Alden Parry, CCRC, BA

Role: CONTACT

bparry@mgh.harvard.edu

617-724-4758

Facility Contacts

Blair Alden Parry, CCRC, BA

Role: primary

bparry@mgh.harvard.edu

617-724-4758

References

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.

Reference Type: DERIVED

PMID: 39532350 (View on PubMed)

Other Identifiers

2023P000252

Identifier Type: -

Identifier Source: org_study_id