Thoracic InjuriesNCT00615979
Far Forward Battlefield Telemedicine: Evaluation of Handheld Ultrasound
An observational study of Thoracic Injuries, run by The Cleveland Clinic.
Trial summary
The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Injuries
- What is being tested?
- Miniature echo machine
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for clinical echocardiographic study Patients with possible diagnosis of cardiac tamponade
Who may be able to join
- 18-80 yrs old
- Scheduled for clinical echocardiogram
Who cannot join
- None
About this study
Official title: Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)
The goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics.
Read the 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
- Thoracic Injuries
- Being tested
- Miniature echo machine
- Keywords
- trauma, portable ultrasound, telemedicine, Department of Defense
- Medical subject headings
- Thoracic Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniature echo machineDevice
Images captured and real-time and store-and-forward file transfers performed
| Study group | Role | What they receive |
|---|---|---|
| Miniature echo machine | Diagnostic capabilities Wireless transfer Receives: Device: Miniature echo machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startOct 2002
- Primary completionDec 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic InjuriesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- James Thomas, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615979
- Sponsor's protocol ID
- 5279
- Other IDs
- DAMD17-02-2-0040
- Status last verified
- Jan 2017
- First submitted
- 26 Dec 2007
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Forward Battlefield Telemedicine:Ultrasound Guidance System (UGS)
- ClinicalTrials.gov ID
- NCT00615979
- Acronym / sponsor ID
- 5279
- Conditions
- Thoracic Injuries
- Keywords
- trauma, portable ultrasound, telemedicine, Department of Defense
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2002 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miniature echo machine | – | Device: Miniature echo machineDiagnostic capabilities Wireless transfer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for clinical echocardiographic study Patients with possible diagnosis of cardiac tamponade
Key inclusion criteria (2 listed)
- 18-80 yrs old
- Scheduled for clinical echocardiogram
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miniature echo machineImages captured and real-time and store-and-forward file transfers performed | Device | Miniature echo machine |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Thomas, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Injuries, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of small portable ultrasound units (time frame: single time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.