Non-invasive hemodynamic measurements for Pulmonary Embolism

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ronald Reagan UCLA Medical Center, Los Angeles, CA
Pulmonary Embolism+7 More
Non-invasive hemodynamic measurements - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a non-invasive blood pressure monitor can detect changes in stroke volume in people with acute pulmonary embolism.

See full description

Eligible Conditions

  • Pulmonary Embolism
  • Pulmonary Embolism Subacute Massive
  • Pulmonary Embolism and Thrombosis
  • Pulmonary Diseases
  • Pulmonary Embolism Acute Massive

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pulmonary Embolism

Study Objectives

This trial is evaluating whether Non-invasive hemodynamic measurements will improve 7 primary outcomes in patients with Pulmonary Embolism. Measurement will happen over the course of 12-24 hours.

12-24 hours
blood pressure (BP)
cardiac index (CI)
cardiac output (CO)
heart rate (HR)
stroke volume (SV)
stroke volume index (SVI)
systemic vascular resistance (SVR)

Trial Safety

Safety Progress

1 of 3

Other trials for Pulmonary Embolism

Trial Design

1 Treatment Group

Patients diagnosed with Pulmonary Embolism
1 of 1
Experimental Treatment

This trial requires 40 total participants across 1 different treatment group

This trial involves a single treatment. Non-invasive Hemodynamic Measurements is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Patients diagnosed with Pulmonary Embolism
Device
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Non-invasive hemodynamic measurements
2018
N/A
~120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12-24 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12-24 hours for reporting.

Who is running the study

Principal Investigator
R. N. C.
Prof. Richard N. Channick, Professor of Medicine
University of California, Los Angeles

Closest Location

Ronald Reagan UCLA Medical Center - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient ≥ 18 years of age.
The patient must understand and sign informed consent form (ICF).
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.
If a patient already has non-invasive hemodynamic monitoring by the Edwards system or by other systems, such as the Cheetah NICOM system, as part of their standard of care, this patient can still be enrolled. If the patient is already being followed by another system such as NICOM, the Edwards system would be added to it as long as the patient consents.

Patient Q&A Section

How many people get pulmonary embolism a year in the United States?

"There are approximately 60,000 pulmonary emboli per year in the Unites States. A high proportion have no symptomatology. Many people hospitalized for PE have pulmonary hypertension." - Anonymous Online Contributor

Unverified Answer

How does non-invasive hemodynamic measurements work?

"Non-invasive hemodynamic measures are helpful in the diagnosis of PE but only in patients with normal heart function. Hemodynamic methods alone are insufficient for diagnosis of other forms of PE." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving non-invasive hemodynamic measurements?

"Non-invasive and inexpensive hemodynamic monitoring using PACS seems to be a safe and promising tool to predict outcome of patients undergoing cardiopulmonary resuscitation, and a large-scale prospective study seems an option." - Anonymous Online Contributor

Unverified Answer

Can pulmonary embolism be cured?

"This report highlights some potentially curative cases of pulmonary embolism, using different treatment strategies. Although this report is limited by single-center studies, and as such this cannot show a cure rate for pulmonary embolism, it highlights some specific cases with significant benefit from treatment." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pulmonary embolism?

"The majority of patients who present to the emergency department with a suspected diagnosis of pulmonary embolism do not have a contraindication to anticoagulation. A careful history and physical exam are the most useful tools, as well as simple tests that evaluate for the presence of pulmonary embolism or its severity. Physicians should also consider the risks and benefits of anticoagulation, because some patients may be appropriate candidates for anticoagulation and others may not. Appropriate patient education and discussion regarding risks and benefits of anticoagulation is of paramount importance." - Anonymous Online Contributor

Unverified Answer

What are the signs of pulmonary embolism?

"Those at risk of pulmonary embolism have higher B-type natriuretic peptide levels, a greater cardiac index, and larger right ventricular end-diastolic volumes than are seen in those without pulmonary arterial hypertension." - Anonymous Online Contributor

Unverified Answer

What causes pulmonary embolism?

"Factors that increase the risk of developing PE include: BMI under 18.5 kg/m, smoking, previous VTE, recent respiratory infection, and high baseline D-dimer levels. The majority of PE results from an embolus that is either sub-segmental (30%) or massive (70%).\n" - Anonymous Online Contributor

Unverified Answer

What is pulmonary embolism?

"Pulmonary embolism is a medical emergency with rapid progression toward death if untreated. PTE is an uncommon cause of sudden death. The incidence is unknown though several estimates have been made. PTE also has multiple subtypes that are now well characterized and can be differentiated by chest CT." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of non-invasive hemodynamic measurements?

"Most of the side effects of these monitoring devices are related to the arterial puncture site and/or the blood flow interruption or the presence of venous clotting. Monitoring in the right upper chamber of the heart has the greatest probability of being related to a serious side effect. In our study, patients having implanted a pressure device for a long time showed a lower occurrence of this complication. Other side effects were as common." - Anonymous Online Contributor

Unverified Answer

Is non-invasive hemodynamic measurements typically used in combination with any other treatments?

"An improved prognostic profile for in-hospital mortality and length of stay in patients receiving non-invasive hemodynamic measurements as part of the initial management of severe sepsis was noted in patients treated at high-volume hospitals as compared with patients treated at low-volume hospitals." - Anonymous Online Contributor

Unverified Answer

What does non-invasive hemodynamic measurements usually treat?

"Measurement of pulse wave velocity and non-invasive central artery pressure might provide a reasonable substitute for invasive hemodynamic measurements, particularly in treating the elderly. Data from a recent study may lead physicians to consider the use of these non-invasive hemodynamic measurements instead of invasive hemodynamic measurements as a first line approach to treating patients with acute PE." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for pulmonary embolism?

"Physicians who are contemplating an individual patient clinical trial for PE should consider the potential risk of pneumonitis and pulmonary embolism. Clinicians should consider the risk-benefit profile of individual patient and clinician risk-benefit ratios. At the time of referral, physicians may wish to consider the possibility that individual patient clinical trials may be of benefit to select PE patients or the subset of patients with the potential to derive the greatest benefit." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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