Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

Thoracic Injuries Clinical Trial

Official title:

Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615979
• Other study ID #: 5279
• Secondary ID: DAMD17-02-2-0040
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: January 26, 2017
• Start date: October 2002
• Est. completion date: May 2009

Study information

• Verified date: January 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 yrs old

• Scheduled for clinical echocardiogram

Exclusion Criteria:

Related Conditions & MeSH terms

• Thoracic Injuries

Intervention

Device:
• Miniature echo machine
Images captured and real-time and store-and-forward file transfers performed

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	United States Department of Defense

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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