Far Forward Battlefield Telemedicine: Evaluation of Handh... | NCT00615979

Studies
Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

NCT00615979

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Jan 27, 2017Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Thoracic Injuries

Interventions

Miniature echo machine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
DAMD17-02-2-0040	Other Identifier	USAMRMC

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002Actual

Primary Completion Date

Dec 2008Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Feb 13, 2008

First Posted Date

Feb 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2017

Last Update Posted Date

Jan 27, 2017Estimated

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Miniature echo machine		Diagnostic capabilities Wireless transfer	Device: Miniature echo machine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Miniature echo machine	Device	Images captured and real-time and store-and-forward file transfers performed	Miniature echo machine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-80 yrs old
Scheduled for clinical echocardiogram

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
James Thomas, MD	The Cleveland Clinic	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013898	Thoracic Injuries
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided