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NCT01981629 Clinical Trial

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

Shock Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01981629
Other study ID # 12-3496
Secondary ID
Status Completed
Phase N/A
First received October 24, 2013
Last updated October 23, 2014
Start date July 2012
Est. completion date August 2013

Study information
Verified date October 2014
Source Minneapolis Medical Research Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• USCOM
The USCOM device will be used in addition to cardiac ultrasound in patients with shock.

Locations
Country Name City State
United States Hennepin County Medical Center Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac Output Cardiac ultrasound findings will be compared to cardiac index and output from the USCOM device Twice during ED visit, averaging one hour No
Secondary Patient outcomes Data will be collected on outcomes of patients including death, length of ICU stay, length of hospital stay, and diagnosis. After emergency department visit No
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