Supplemental Oxygen in Pulmonary Embolism (SO-PE)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05891886
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Metabolomics
  • Oxygen Inhalation Therapy
  • Pulmonary Embolism
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxygen Therapy — DRUG
    Study subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
  • Non-rebreather mask — DEVICE
    Non-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Pulmonary artery systolic pressure (PASP) [ Time Frame: 30 minutes after study treatment (supplemental oxygen) or placebo (room air) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Blair Alden Parry, CCRC, BA
[email protected]
617-724-4758
Christopher Kabrhel, MD, MPH (PRINCIPAL_INVESTIGATOR)

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Massachusetts General Hospital· Boston, MA

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