Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Early Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Christopher Kabrhel, MD, MPH
ckabhrel@mgb.org
617-726-7622
Backup
Blair Alden Parry, CCRC, BA
bparry@mgh.harvard.edu
617-724-4758
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 80
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Aarhus University Hospital