Back to resultsSupplemental Oxygen in Pulmonary Embolism (SO-PE) (SO-PE)
Primary Purpose
Pulmonary Embolism, Venous Thromboembolism, Metabolomics
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxygen Therapy
Non-rebreather mask
Sponsored by
About this trial
This is an interventional other trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, PE, RVD
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supplemental oxygen delivered by facemask
Room air delivered by facemask
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Secondary Outcome Measures
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
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.
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.
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.
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.
Full Information
NCT ID
NCT05891886
First Posted
May 4, 2023
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
Collaborators
University of Aarhus, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05891886
Brief Title
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Acronym
SO-PE
Official Title
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
University of Aarhus, National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
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.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Venous Thromboembolism, Metabolomics, Oxygen Inhalation Therapy
Keywords
Pulmonary Embolism, PE, RVD
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supplemental oxygen delivered by facemask
Arm Type
Experimental
Arm Description
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.
Arm Title
Room air delivered by facemask
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxygen Therapy
Intervention Description
Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
Intervention Type
Device
Intervention Name(s)
Non-rebreather mask
Other Intervention Name(s)
NRM (Non-rebreather mask)
Intervention Description
Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.
Primary Outcome Measure Information:
Title
Pulmonary artery systolic pressure (PASP)
Description
PASP is measured on bedside echocardiogram
Time Frame
30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Pulmonary artery systolic pressure (PASP)
Description
PASP is measured on bedside echocardiogram
Time Frame
60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Pulmonary artery systolic pressure (PASP)
Description
PASP is measured on bedside echocardiogram
Time Frame
90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Pulmonary artery systolic pressure (PASP)
Description
PASP is measured on bedside echocardiogram
Time Frame
180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Secondary Outcome Measure Information:
Title
Right ventricular to left ventricular ratio (RV/LV)
Description
RV/LV ratio is measured on bedside echocardiogram
Time Frame
30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Right ventricular to left ventricular ratio (RV/LV)
Description
RV/LV ratio is measured on bedside echocardiogram
Time Frame
60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Right ventricular to left ventricular ratio (RV/LV)
Description
RV/LV ratio is measured on bedside echocardiogram
Time Frame
90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Right ventricular to left ventricular ratio (RV/LV)
Description
RV/LV ratio is measured on bedside echocardiogram
Time Frame
180 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Description
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Time Frame
30 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Description
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Time Frame
60 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Description
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Time Frame
90 minutes after study treatment (supplemental oxygen) or placebo (room air)
Title
Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays
Description
Investigators will perform high-throughput metabolomics to identify changes in circulating blood metabolites associated with supplemental oxygen use in patients with acute PE.
Time Frame
180 minutes after study treatment (supplemental oxygen) or placebo (room air)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Kabrhel, MD, MPH
Phone
617-726-7622
Email
ckabhrel@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Blair A Parry, CCRC, BA
Phone
617-724-4758
Email
bparry@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kabrhel, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair A Parry
Phone
617-724-4758
Email
bparry@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Christopher Kabrhel, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers.
The results of this study will be published in scientific journals and presented at national/international scientific meetings.
Learn more about this trial
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
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