Non-Invasive Hemodynamic Monitoring for Pulmonary Embolism

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Atrial fibrillation, Valve insufficiency, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12-24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how non-invasive blood pressure monitors can help manage pulmonary embolism (PE), a serious condition where blood clots block the blood vessels in the lungs. Researchers will focus on measuring and monitoring stroke volume (the amount of blood pumped by the heart with each beat) to observe changes during treatment. This could improve understanding of how the heart copes with PE and help predict patient outcomes more accurately. Suitable candidates for this trial include those diagnosed with PE who require intensive care. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research that could enhance future PE treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this non-invasive hemodynamic monitoring is safe for patients with pulmonary embolism?

Research has shown that non-invasive methods to monitor blood flow and heart function are safe in many medical settings. These methods use devices like finger cuffs to assess heart function without surgery or needles. Studies have found that these non-invasive monitors provide real-time information about heart health, which is crucial for individuals with conditions like blood clots in the lungs.

This non-invasive approach is generally easy for patients to handle and carries a low risk of side effects. These monitors are often considered safer than traditional methods involving surgery or needles. While research has not reported specific side effects for this type of monitoring, the non-invasive nature itself reduces the likelihood of complications. This should reassure participants about the safety of joining a trial that uses non-invasive heart monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about non-invasive hemodynamic monitoring for pulmonary embolism because it offers a way to assess heart and lung function without the need for invasive procedures. Traditional treatments for pulmonary embolism often involve anticoagulant medications and, in severe cases, surgical interventions like catheter-directed thrombolysis. This new method provides critical information about blood flow and pressure in real-time, potentially helping doctors make quicker and more accurate treatment decisions. By eliminating the need for invasive techniques, this approach could reduce patient risk and improve recovery times.

What evidence suggests that non-invasive hemodynamic monitoring is effective for pulmonary embolism?

Research has shown that non-invasive methods to measure heart function can greatly improve care for patients with a pulmonary embolism (PE). In this trial, participants will undergo non-invasive hemodynamic monitoring to track stroke volume, the amount of blood the heart pumps with each beat, in real-time. Studies indicate that monitoring stroke volume helps doctors predict and manage heart issues during a PE. Non-invasive techniques, such as using finger cuffs with sensors, allow for continuous monitoring without surgery or other invasive procedures. Early research suggests this approach could lead to better outcomes by detecting heart problems early and allowing for quick treatment adjustments. ^{2 3 4 6 7}

Who Is on the Research Team?

Richard Channick, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults over 18 in intensive care with confirmed pulmonary embolism (PE) who can sign a consent form. It's not for those under 120 cm tall, on ECMO, with BMI <20 or >35, atrial fibrillation, certain heart valve issues, scleroderma, or end-stage renal disease.

Inclusion Criteria

I was diagnosed with a lung clot and needed ICU care before or soon after starting treatment.

The patient must understand and sign informed consent form (ICF)

If a patient is already using a specific monitoring system, they can still join the study. If they are using a different system, the Edwards system can be added as long as the patient agrees.

Exclusion Criteria

I am shorter than 120 cm.

You are currently using a machine to help your heart and lungs work.

You are either underweight with a low BMI or significantly overweight with a high BMI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients with confirmed PE are monitored using non-invasive hemodynamic measurement devices for 12 to 24 hours

12-24 hours

Continuous monitoring during ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment through their hospitalization

Duration of hospitalization

What Are the Treatments Tested in This Trial?

Interventions

• Non-invasive hemodynamic measurements

Trial Overview

The study tests non-invasive blood pressure monitors to measure cardiac output and stroke volume in PE patients. It aims to see how these measurements relate to PE outcomes and change with treatment.

How Is the Trial Designed?

Group I: Patients diagnosed with Pulmonary Embolism Experimental Treatment 1 Intervention

Patients requiring intensive care unit (ICU) level care with a confirmed diagnosis of pulmonary embolism (PE) by computed tomography (CT) angiogram or endobronchial ultrasound (EBUS) prior to or within 4 hours of initiation of any PE therapy or intervention.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10272848/

Hemodynamic and respiratory support in pulmonary embolism

In this review, we critically discuss and summarize the current literature concerning the hemodynamic and respiratory support in pulmonary embolism.

2.

respiratory-research.biomedcentral.com

respiratory-research.biomedcentral.com/articles/10.1186/s12931-023-02552-w

Mechanical thrombectomy in intermediate- and high-risk acute ...

Mechanical thrombectomy for acute PE was safe and immediately reduced PAP and improved right heart function. The reduction in PAP was maintained at three ...

3.

icrjournal.com

icrjournal.com/articles/role-non-invasive-tests-pulmonary-embolism?language_content_entity=en

The Role of Non-invasive Tests in Pulmonary Embolism

Explore the significance of non-invasive tests in detecting pulmonary embolism, enhancing patient care and treatment efficiency.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8584279/

Non-Invasive Continuous Measurement of Haemodynamic ...

This paper aims to analyse the commonly used techniques of haemodynamic parameters' measurements and to describe the possibilities of currently available non- ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772963X25005186

Assessing Cardiac Flow Measurements Using a ...

The aim of the study was to compare invasive hemodynamic measurements using a noninvasive wearable photoplethysmography-based (PPG) monitor and an invasive ...

6.

withpower.com

withpower.com/trial/phase-embolism-8-2021-552f9

Non-Invasive Hemodynamic Monitoring for Pulmonary ...

Our clinical study proposes to monitor hemodynamic parameters including stroke volume in patients with acute pulmonary embolism using non-invasive blood ...

7.

mdpi.com

mdpi.com/2077-0383/14/19/7002

Non-Invasive Hemodynamic Monitoring in Critically Ill ...

It allows for real-time analysis of cardiac function, blood volume status, and fluid therapy response, without the need for advanced diagnostic facilities [38].