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Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

This study has been completed.
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00615979
First received: December 26, 2007
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics.

Condition Intervention
Thoracic Injuries
Device: Miniature echo machine

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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


Enrollment: 120
Actual Study Start Date: October 2002
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Miniature echo machine
Diagnostic capabilities Wireless transfer
Device: Miniature echo machine
Images captured and real-time and store-and-forward file transfers performed

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.
  Eligibility

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
Criteria

Inclusion Criteria:

  • 18-80 yrs old
  • Scheduled for clinical echocardiogram

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615979

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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00615979     History of Changes
Other Study ID Numbers: 5279
DAMD17-02-2-0040 ( Other Identifier: USAMRMC )
Study First Received: December 26, 2007
Last Updated: January 26, 2017
Individual Participant Data  
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:
trauma
portable ultrasound
telemedicine
Department of Defense

Additional relevant MeSH terms:
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 26, 2017