NCT00615979

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2002

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

6.2 years

First QC Date

December 26, 2007

Last Update Submit

January 26, 2017

Conditions

Thoracic Injuries

Keywords

traumaportable ultrasoundtelemedicineDepartment of Defense

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Miniature echo machine

Diagnostic capabilities Wireless transfer

Device: Miniature echo machine

Interventions

Miniature echo machineDEVICE

Images captured and real-time and store-and-forward file transfers performed

Miniature echo machine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • yrs old
  • Scheduled for clinical echocardiogram

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thoracic InjuriesWounds and Injuries

Study Officials

  • James Thomas, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 14, 2008

Study Start

October 1, 2002

Primary Completion

December 1, 2008

Study Completion

May 1, 2009

Last Updated

January 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share