The Use of the USCOM Device in Addition to Cardiac Ultrasound in Patients Undergoing Treatment for Undifferentiated Shock

October 23, 2014 updated by: Hennepin Healthcare Research Institute
Currently, bedside ultrasound (US) is performed routinely in emergency department (ED) patients with undifferentiated shock to help guide resuscitation. Previously, it has never been possible to measure cardiac output on patients in the ED. Our clinical question looks at whether the USCOM device gives clinically relevant information in addition to ED cardiac US in patients with shock.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the emergency department at an urban county hospital.

Description

Inclusion Criteria:

  • Patients in shock, as defined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9

Exclusion Criteria:

  • less than 18 years old
  • Pregnant
  • Patients in shock due to trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Shock
Defined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9
Device: USCOM
The USCOM device will be used in addition to cardiac ultrasound in patients with shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output
Time Frame: Twice during ED visit, averaging one hour
Cardiac ultrasound findings will be compared to cardiac index and output from the USCOM device
Twice during ED visit, averaging one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient outcomes
Time Frame: After emergency department visit
Data will be collected on outcomes of patients including death, length of ICU stay, length of hospital stay, and diagnosis.
After emergency department visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Investigators

  • Principal Investigator: Johanna C Moore, MD, Hennepin Healthcare Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-3496

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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