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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05891886
Other study ID # 2023P000252
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


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)
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