## Protocol Section
### Identification Module
**NCT ID:** NCT00615979

**Brief Title:** Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound

**Official Title:** Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)

#### Organization Study ID Info
**ID:** 5279
#### Organization
**Class:** OTHER
**Full Name:** The Cleveland Clinic
#### Secondary ID Infos
**Domain:** USAMRMC
**ID:** DAMD17-02-2-0040
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2009-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-01-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-01-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Start Date
**Date:** 2002-10

**Type:** ACTUAL

**Status Verified Date:** 2017-01

#### Study First Post Date
**Date:** 2008-02-14
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-26
**Study First Submit QC Date:** 2008-02-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** United States Department of Defense

#### Lead Sponsor

**Class:** OTHER

**Name:** The Cleveland Clinic

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Thoracic Injuries

**Keywords:**

- trauma

- portable ultrasound

- telemedicine

- Department of Defense

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Diagnostic capabilities Wireless transfer

**Intervention Names:**

- Device: Miniature echo machine

**Label:** Miniature echo machine

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Miniature echo machine

**Description:** Images captured and real-time and store-and-forward file transfers performed

**Name:** Miniature echo machine

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Validation of small portable ultrasound units

**Time Frame:** single time point

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18-80 yrs old
* Scheduled for clinical echocardiogram

Exclusion Criteria:

* None

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients scheduled for clinical echocardiographic study Patients with possible diagnosis of cardiac tamponade

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** The Cleveland Clinic

**Name:** James Thomas, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M16657

- Name: Thoracic Injuries

- Relevance: HIGH

- As Found: Thoracic Injuries

### Condition Browse Module - Meshes

- ID: D000013898

- Term: Thoracic Injuries

### Misc Info Module

- Version Holder: 2024-05-24
