Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWellSpan Health

About this trial

This study is an observational, prospective study examining the role point-of-care echocardiography of predicting short term adverse outcomes in emergency department patients with acute pulmonary embolism.

The primary objective is to assess the diagnostic performance of ultrasound-guided measures of right ventricular dilation (RVD) and strain in predicting clinical outcomes in acute PE.

The secondary objective is to investigate the utility of combining ultrasound-guided measures of RVD and the pulmonary embolism severity index (PESI) score in predicting adverse outcomes in acute PE.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years of age

ED diagnosis of acute pulmonary embolism with identification on CT imaging

Disqualifiers

Age <18 years of age

Inability to provide informed consent

Incarceration

Current PE previously diagnosed prior to index ED visit

Trial population

The study population consists of ED patients over the age of 18 who have an acute pulmonary embolism identified on CT imaging.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Point-of-care echocardiography

    Diagnostic test

    Subjects will undergo point-of-care echocardiography at the time of presentation/enrollment to assess for evidence of right sided heart dilation/strain.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Acute Pulmonary Embolism1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events at 5 days

Composite of recurrent/worsening VTE (including PE or DVT), new cardiac dysrhythmia, major bleeding, return to the ED, death or need for critical interventions (including advanced cardiac life support, advanced respiratory support, vasopressor support, thrombolysis or new oxygen requirement occurring after initial presentation) occurring within 5 days of acute PE diagnosis

Time frame
Within 5 days of presentation/enrollment

Secondary outcomes

1

Adverse Events during Index Hospitalization

Composite of mortality, major bleeding or recurrent/worsening PE during index hospitalization

Time frame
Between time of presentation/enrollment and discharge from index hospitalization
2

Adverse Events within 14 days

Composite of mortality, major bleeding or recurrent/worsening PE within 14 days of presentation/enrollment

Time frame
Within 14 days of presentation/enrollment
3

Adverse Events within 30 days

Composite of mortality, major bleeding or recurrent/worsening PE within 30 days of presentation/enrollment

Time frame
Within 30 days of presentation/enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

WellSpan Health

Lead sponsor

Stony Brook University

Collaborator

University of California, Irvine

Collaborator