Oxygen Therapy for Pulmonary Embolism
(SO-PE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Vasodilators
Disqualifiers: Hemodynamic instability, COPD, CHF, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used vasodilator medication in the past 24 hours.
What data supports the effectiveness of oxygen therapy for pulmonary embolism?
The research suggests that while oxygen therapy is commonly used, its specific effectiveness for pulmonary embolism, especially in patients without low oxygen levels, is uncertain. However, combining oxygen with other treatments like inhaled nitric oxide may improve heart function and breathing in some patients with pulmonary embolism.12345
Is oxygen therapy safe for humans?
How is oxygen therapy different from other treatments for pulmonary embolism?
Oxygen therapy for pulmonary embolism is unique because it focuses on providing supplemental oxygen to improve oxygen levels in the blood, unlike other treatments that primarily aim to dissolve or remove the blood clot, such as thrombolysis or surgical procedures. This approach can be particularly beneficial for patients experiencing severe breathing difficulties due to the embolism.29101112
Eligibility Criteria
Adults over 18 with a recent pulmonary embolism confirmed by imaging, who can breathe on their own with oxygen saturation above 90%. Not for those unstable after the event, with new heart rhythm issues, pregnant, or on certain medications. Must be able to wear an oxygen mask.Inclusion Criteria
Your oxygen level is at least 90% when you breathe normally without any extra oxygen.
I was diagnosed with a lung clot by a CT scan less than 24 hours ago.
My symptoms started less than 3 days ago.
See 2 more
Exclusion Criteria
My symptoms started more than 72 hours ago.
I am scheduled for a clot-dissolving treatment or clot removal surgery.
I have taken medication to widen my blood vessels in the last 24 hours.
See 11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive alternating treatments of supplemental oxygen or room air every 30 minutes for 90 minutes, followed by maintenance of the treatment for a total of 180 minutes
180 minutes
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
Treatment Details
Interventions
- Non-rebreather mask (Device)
- Oxygen Therapy (Supplemental Oxygen)
Trial OverviewThe trial is testing if supplemental oxygen given through a non-rebreather mask can help manage acute pulmonary embolism by reducing stress on the right side of the heart and lowering blood pressure in lung arteries due to low oxygen levels.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Supplemental oxygen delivered by facemaskExperimental Treatment2 Interventions
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.
Group II: Room air delivered by facemaskActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
University of AarhusCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Randomized trial of inhaled nitric oxide to treat acute pulmonary embolism: The iNOPE trial. [2023]The study hypothesis is that administration of inhaled nitric oxide (NO) plus oxygen to subjects with submassive pulmonary embolism (PE) will improve right ventricular (RV) systolic function and reduce RV strain and necrosis, while improving patient dyspnea, more than treatment with oxygen alone.
Interventional therapies in acute pulmonary embolus-current trends and future directions. [2023]Venous thromboembolic disease presenting with acute pulmonary embolus (PE) can be treated in a variety of ways from anticoagulation as an outpatient to surgical embolectomy with many new interventional therapies being developed. Mortality in these patients can be as high as 50% and many of these treatments are also considered to be high risk. Early involvement of a multidisciplinary team and patient risk stratification can aid management decisions in these complex patients who can suddenly deteriorate.In this review, we summarise the evidence behind new and developing interventional therapies in the treatment of high and intermediate-high risk PE including catheter-directed thrombolysis, pharmacomechanical thrombolysis, thromboaspiration and the growing role of extracorporeal membrane oxygenation in the stabilisation and management of this cohort of patients.
Oxygen Therapy in Patients With Intermediate-Risk Acute Pulmonary Embolism: A Randomized Trial. [2023]The effect of supplemental oxygen therapy in patients with intermediate-risk pulmonary embolism (PE) who do not have hypoxemia at baseline is uncertain.
Pulmonary embolism: treatment of the acute episode. [2005]The prognosis of acute pulmonary embolism (PE) is mainly related to the clinical presentation and circulatory state of the patient: the therapeutic strategy is consequently different, ranging from an aggressive treatment in patients in life-threatening clinical conditions to a "stabilization" treatment in those hemodynamically stable. Since the majority of PE patients are clinically stable, a well conducted anticoagulant therapy, either with unfractionated or low-molecular-weight heparins together with a vitamin K antagonist, is sufficient to stop thrombus extension, to minimize the risk of recurrent embolism and prevent mortality. In about 15-20% of cases presenting with clinical instability of variable severity, prompt intravenous thrombolysis with a short-acting compound often represents a life-saving treatment and should be the first-line approach. In normotensive patients with right ventricular dysfunction at echocardiography, who represent about 30% of PE patients, the debate regarding the optimal therapy is still open and further studies are required to document a clinically relevant improvement in the benefit-risk ratio of thrombolytic agents over heparin alone: young people, with a very low risk of bleeding and a concomitant reduction of cardiopulmonary reserve might be the best candidates to systemic thrombolysis. In any case such patients should be admitted to an intensive care unit to monitor the clinical status for at least 48-72 hours and detect signs of possible hemodynamic worsening. Mechanical thrombectomy, either percutaneous or surgical, are ancillary procedures and should be reserved to a minority of highly compromised patients who are unable to receive thrombolysis.
An Update on the Management of Acute High-Risk Pulmonary Embolism. [2022]Hemodynamic instability and right ventricular (RV) dysfunction are the key determinants of short-term prognosis in patients with acute pulmonary embolism (PE). High-risk PE encompasses a wide spectrum of clinical situations from sustained hypotension to cardiac arrest. Early recognition and treatment tailored to each individual are crucial. Systemic fibrinolysis is the first-line pulmonary reperfusion therapy to rapidly reverse RV overload and hemodynamic collapse, at the cost of a significant rate of bleeding. Catheter-directed pharmacological and mechanical techniques ensure swift recovery of echocardiographic parameters and may possess a better safety profile than systemic thrombolysis. Further clinical studies are mandatory to clarify which pulmonary reperfusion strategy may improve early clinical outcomes and fill existing gaps in the evidence.
Comparison of interventions for intermediate to high-risk pulmonary embolism: A network meta-analysis. [2023]Multiple interventions, including catheter-directed therapy (CDT), systemic thrombolysis (ST), surgical embolectomy (SE), and therapeutic anticoagulation (AC) have been used to treat intermediate to high-risk pulmonary embolism (PE), but the most effective and safest treatment remains unclear. Our study aimed to investigate the efficacy and safety outcomes of each intervention.
Low-dose urokinase thrombolytic therapy for patients with acute intermediate-high-risk pulmonary embolism: A retrospective cohort study. [2021]Patients at intermediate-high risk of developing a pulmonary embolism (PE) are very likely to experience adverse outcomes, such as cardiovascular instability and death. The role of thrombolytic therapy in intermediate-high-risk PE remains controversial.
Thrombolysis in pulmonary embolism: an adolescent with protein S deficiency. [2016]Because of the low incidence of pulmonary embolism in children, the therapeutic approach is extrapolated from guidelines for adults. An adolescent boy with a massive pulmonary embolism associated with protein S deficiency was cared for successfully with intravenous thrombolytic therapy using 1.3 mg/kg of rt-PA with a 2-hour infusion time. In the absence of contraindications, most physicians consider using thrombolytic drugs in hemodynamically unstable patients who have a pulmonary embolism. A recent study described a subset of hemodynamically stable patients with right-ventricular dysfunction who also might benefit from thrombolytic therapy.
Thrombolysis for pulmonary embolism and risk of all-cause mortality, major bleeding, and intracranial hemorrhage: a meta-analysis. [2022]Thrombolytic therapy may be beneficial in the treatment of some patients with pulmonary embolism. To date, no analysis has had adequate statistical power to determine whether thrombolytic therapy is associated with improved survival, compared with conventional anticoagulation.
Use of extracorporeal membrane oxygenation in patients with acute high-risk pulmonary embolism: a case series with literature review. [2022]Although extracorporeal membrane oxygenation (ECMO) has been used for the treatment of acute high-risk pulmonary embolism (PE), there are limited reports which focus on this approach. Herein, we described our experience with ECMO in patients with acute high-risk PE.
Pulmonary thromboembolectomy for acute pulmonary thromboembolism. [2022]Acute pulmonary thromboembolism is fatal because of abruptly occurring hypoxemia and right ventricular failure. There are several treatment modalities, including anticoagulation, thrombolytics, ECMO (extracorporeal membrane oxygenator), and thromboembolectomy, for managing acute pulmonary thromboembolism.
Massive Pulmonary Embolism Treated with Catheter Therapy and Extracorporeal Membrane Oxygenation. [2018]Massive pulmonary embolism (PE) is associated with significant morbidity and mortality. Treatment for massive PE can include systemic thrombolysis and catheter-directed therapy. We present the case of a patient with massive PE successfully treated with catheter-directed therapy, using extracorporeal membrane oxygenation for hemodynamic support, and discuss some of the potential complications associated with this therapy.