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Device

Non-Invasive Hemodynamic Monitoring for Pulmonary Embolism

N/A
Waitlist Available
Led By Richard N Channick, M.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Patient ≥ 18 years of age
Must not have
Height less than 120 cm
Diagnosis of atrial fibrillation, moderate to severe aortic or mitral valve insufficiency or stenosis, scleroderma, or end-stage renal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether monitoring stroke volume with non-invasive blood pressure monitors can help manage patients with acute pulmonary embolism.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves non-invasive monitoring without drugs or invasive procedures, significant side effects are not expected. However, discomfort from wearing the monitor may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with a lung clot and needed ICU care before or soon after starting treatment.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am shorter than 120 cm.
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I have been diagnosed with a heart valve issue, scleroderma, or severe kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
blood pressure (BP)
cardiac index (CI)
cardiac output (CO)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients diagnosed with Pulmonary EmbolismExperimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Non-invasive hemodynamic measurements
2018
N/A
~120

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,561 Previous Clinical Trials
10,258,966 Total Patients Enrolled
3 Trials studying Pulmonary Embolism
294 Patients Enrolled for Pulmonary Embolism
Richard N Channick, M.D.Principal InvestigatorUniversity of California, Los Angeles

Media Library

Non-invasive hemodynamic measurements (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04855370 — N/A
Pulmonary Embolism Research Study Groups: Patients diagnosed with Pulmonary Embolism
Pulmonary Embolism Clinical Trial 2023: Non-invasive hemodynamic measurements Highlights & Side Effects. Trial Name: NCT04855370 — N/A
Non-invasive hemodynamic measurements (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855370 — N/A
~7 spots leftby Jan 2025
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