Supplemental Oxygen in Pulmonary Embolism (SO-PE)
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hemodynamic instability
Use of vasopressors or mechanical circulatory support
Planned use of thrombolytics or plan for embolectomy
Oxygen saturation <90% while breathing room air
Trial design
Design model
Crossover
Treatments tested in this trial
Oxygen Therapy
DrugStudy subjects will be asked to breathe supplemental, or extra, oxygen during several time periods.
Non-rebreather mask
DeviceNon-rebreather mask is a non-invasive oxygen supplementation device that is used to provide continuous oxygen flow, typically in a hospital setting.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Supplemental oxygen delivered by facemaskExperimental treatment 2 interventions
Group B: Room air delivered by facemaskActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame
30 minutes after study treatment (supplemental oxygen) or placebo (room air)2
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame
60 minutes after study treatment (supplemental oxygen) or placebo (room air)3
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame
90 minutes after study treatment (supplemental oxygen) or placebo (room air)4
Pulmonary artery systolic pressure (PASP)
PASP is measured on bedside echocardiogram
Time frame
180 minutes after study treatment (supplemental oxygen) or placebo (room air)Secondary outcomes
1
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Time frame
30 minutes after study treatment (supplemental oxygen) or placebo (room air)2
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Time frame
60 minutes after study treatment (supplemental oxygen) or placebo (room air)3
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Time frame
90 minutes after study treatment (supplemental oxygen) or placebo (room air)4
Right ventricular to left ventricular ratio (RV/LV)
RV/LV ratio is measured on bedside echocardiogram
Time frame
180 minutes after study treatment (supplemental oxygen) or placebo (room air)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov