Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)

The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics.

Study Overview

• Status: Completed
• Conditions: Thoracic Injuries
• Intervention / Treatment: Device: Miniature echo machine

Detailed Description

Specific aims to meet to improve the survival of battlefield trauma are 1)validation of portable ultrasound for diagnosis of various medical and surgical emergencies, ie cardiac tamponade, intraabdominal hemorrhage, 2)Extension of our expertise in digital echocardiography and local telemedicine to support other centers in such procedures as TEE 3)development of wireless telemedicine systems for rapid relay of ultrasonic images from portable ultrasound system to a remote review station. 4)development of a precision guide for diagnostic and therapeutic percutaneous procedures using ultrasound guidance 5)combining wireless telemetry with the guided percutaneous access tool to permit remotely guided emergency procedures 6)augmenting this work(2D/echo) with 3D/echo.

• Study Type: Observational
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for clinical echocardiographic study Patients with possible diagnosis of cardiac tamponade

Description

Inclusion Criteria:

• 18-80 yrs old
• Scheduled for clinical echocardiogram

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Miniature echo machine; Diagnostic capabilities Wireless transfer	Device: Miniature echo machine; Images captured and real-time and store-and-forward file transfers performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of small portable ultrasound units	paired t-testing and linear regression will be used to test the hypothesis that the small system is equivalent to the full-featured one (mean difference in values not different from 0 and slope of the regression line not different	single time point

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: James Thomas, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2002
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: February 13, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: trauma; telemedicine; portable ultrasound; Department of Defense
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries
• Other Study ID Numbers: 5279; DAMD17-02-2-0040 (Other Identifier: USAMRMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes