Supplemental oxygen for pulmonary embolism (SO-PE): study protocol for a mechanistic, randomised, blinded, cross-over study.
Mads Dam Lyhne, Andrew S Liteplo, Oana Alina Zeleznik...
https://pubmed.ncbi.nlm.nih.gov/39532350Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID05891886
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Led by Massachusetts General Hospital · Updated on 2025-06-15
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how supplemental oxygen affects patients with acute pulmonary embolism (PE). The study focuses on whether oxygen can relieve right ventricular dysfunction (RVD) by reducing pulmonary artery pressure through easing hypoxic pulmonary vasoconstriction. This early-phase trial also investigates the metabolic changes triggered by oxygen therapy in this condition. In the Emergency Department, adult patients diagnosed with acute PE will take part in a randomized, crossover trial. Participants will be assigned to receive either supplemental oxygen or room air through a non-rebreather face mask, with treatments alternating every 30 minutes up to 90 minutes. After this period, the assigned treatment will continue for a total of 180 minutes. During the study, echocardiograms will be performed at multiple time points to assess pulmonary artery systolic pressure and right ventricular function. Blood samples will be collected to analyze metabolomic profiles. The primary outcome measures include pulmonary artery pressure at 30, 60, 90, and 180 minutes, while secondary outcomes assess heart function ratios and circulating metabolites. The entire participation involves close monitoring over the 180-minute treatment period.
CONDITIONS
Brief Title
Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Confirmed pulmonary embolism by imaging within 24 hours before enrollment
- New or worsening symptoms within the last 72 hours
- Confirmed right ventricular dysfunction by a clinician
- Oxygen saturation of 90% or higher while breathing room air
You will not qualify if you...
- Hemodynamic instability
- Use of vasopressors or mechanical circulatory support
- Planned use of thrombolytics or embolectomy
- Oxygen saturation below 90% while breathing room air
- New onset arrhythmia
- History of pulmonary hypertension, severe COPD requiring home oxygen, chronic steroid use, hypoventilation syndrome requiring CPAP or BiPAP, or congestive heart failure with left ventricular ejection fraction below 40% or chronic oxygen therapy
- Known pregnancy
- Use of vasodilator medication in the past 24 hours
- Symptom onset greater than 72 hours ago
- Inability to wear a face mask
- Inability to obtain adequate baseline echocardiogram
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 3 hours
Participants receive alternating treatments of supplemental oxygen or room air delivered by facemask every 30 minutes during the first 90 minutes, followed by continued treatment for a total of 180 minutes. Echocardiograms and blood draws are performed after each treatment change to evaluate heart function and metabolic changes.
1 in-person treatment session with assessments at 30, 60, 90, and 180 minutes
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
C
Christopher Kabrhel, MD, MPH
B
Blair Alden Parry, CCRC, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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