Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615979
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : January 27, 2017
United States Department of Defense
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment
Thoracic Injuries 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
Actual Enrollment : 120 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)
Actual Study Start Date : October 2002
Primary Completion Date : December 2008
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Validation of small portable ultrasound units [ Time Frame: single time point ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for clinical echocardiographic study Patients with possible diagnosis of cardiac tamponade

Inclusion Criteria:

  • 18-80 yrs old
  • Scheduled for clinical echocardiogram

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615979

Sponsors and Collaborators
The Cleveland Clinic
United States Department of Defense
Principal Investigator: James Thomas, MD The Cleveland Clinic

Responsible Party: The Cleveland Clinic Identifier: NCT00615979     History of Changes
Other Study ID Numbers: 5279
DAMD17-02-2-0040 ( Other Identifier: USAMRMC )
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by The Cleveland Clinic:
portable ultrasound
Department of Defense

Additional relevant MeSH terms:
Thoracic Injuries
Wounds and Injuries