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CompletedNCT02719509Updated Aug 26, 2016

Emergency Department Cardiac Ultrasound

An observational study in Chest Pain and Dyspnea, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-26.

Sponsored by Hennepin Healthcare Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
01

Study summary

This is a prospective observational study evaluating the diagnostic utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Emergency department providers will be interviewed before and after the completion of a cardiac ultrasound to determine if the ultrasound resulted in any changes in management. Other outcomes include determination of incidence of unexpected findings.

Read the detailed description

Bedside cardiac ultrasound is performed regularly in the emergency department to assess patients who present with undifferentiated chest pain or shortness of breath. Utility of cardiac ultrasound in this setting is emerging as standard of care. Cardiac ultrasound can rapidly provide essential information about the presence or absence of multiple cardiopulmonary pathologies. Cardiac ultrasound is safe, immediately accessible, and gives providers data regarding their patients in real-time.

While cardiac ultrasound is common practice in emergency departments, the diagnostic utility of this test has been difficult to study. There are few studies in the literature that describe its utility in evaluating specific diagnoses. These studies have evaluated the use of cardiac ultrasound in diagnosing acute cardiogenic pulmonary edema, aortic dilation/aneurysm, acute coronary syndrome, and acute heart failure.

The purpose of this study is to evaluate the utility of cardiac ultrasound in patients who present to the emergency department with undifferentiated chest pain or shortness of breath. This study will evaluate several parameters including how the cardiac ultrasound contributes to provider's management plan and assessment of the patient's diagnosis.

This is a prospective observational study design. The investigators will prospectively enroll eligible consecutive patients who present to the emergency department with undifferentiated chest pain or shortness of breath. Patients will be included if a provider has ordered (or is planning on ordering) a cardiac ultrasound as part of the patient's diagnostic workup. Research associates will screen for these two chief complaints and will then approach the ED provider and ask if they ordered or are planning to order a cardiac ultrasound. ED providers may also contact research associates to enroll patients that meet the study criteria.

Pre-ultrasound assessment: After eligibility is determined, a research associate will approach the provider directly involved in the patient's care (Resident or Staff). The provider completing the data collection forms does not need to be the provider who ordered or performed the ultrasound. The provider completing the forms will be an Emergency Medicine 2nd year level resident or above. The provider filling out the data collection form will fill out the pre-ultrasound assessment prior to reviewing the cardiac ultrasound images (either in real-time or on the computer after the ultrasound is completed). The provider will fill out a data collection form that asks about the most likely diagnosis, expected ultrasound findings, and current management plan.

After the ultrasound is completed the same provider will be asked about the most likely diagnosis, observed ultrasound findings, and any new management changes.

Other clinical data that will be collected will include demographic data, vital signs, relevant co-morbidities, imaging results, and lab results from the emergency department visit.

02

Conditions studied

  • Chest Pain
  • Dyspnea

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03

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 380 is above the median of 122 across 204 observational studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Hennepin Healthcare Research Institute is the lead sponsor of 69 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with undifferentiated chest pain or shortness of breath who have a cardiac ultrasound ordered by the emergency provider as part of the diagnostic workup

Inclusion criteria

  • ED patients with a chief complaint of chest pain or shortness of breath
  • Cardiac Ultrasound ordered by provider as part of diagnostic workup

Exclusion criteria

Exclusion Criteria:

  • All providers have already reviewed the ultrasound images (unable to obtained pre- ultrasound assessment)
  • Age \< 18
  • Known to be pregnant
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
380 participants (actual)
Patient registry
No

Groups and cohorts

  • Observational Cohort

    All emergency department patients who had a cardiac ultrasound performed as part of their diagnostic workup

    Procedure: Cardiac Ultrasound

Interventions

  • ProcedureCardiac Ultrasound
06

What researchers measure

Primary outcomes

  1. Incidence of management changes

    Approximate duration of the emergency department visit

    Time frame: 6 hours

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Study locations

1 site
  • Hennepin County Medical Center
    Minneapolis, Minnesota 55415, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02719509
Lead sponsor
Hennepin Healthcare Research Institute
Responsible party
Sponsor
First posted
Mar 25, 2016
Start date
Feb 2016
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Aug 26, 2016

Study contacts

Lauren Klein, MD
principal investigator · Hennepin Healthcare Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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