U.S. Army Institute of Surgical ResearchU.S. Army Institute of Surgical ResearchFort Sam Houston, TXFort Sam Houston, TX

DisclaimerDisclaimer

• The opinions and assertions contained herein The opinions and assertions contained herein are the private views of the author and are not are the private views of the author and are not to be construed as official or as reflecting the to be construed as official or as reflecting the views of the Department of the Army or the views of the Department of the Army or the Department of Defense.Department of Defense.

• This study was conducted under a protocol This study was conducted under a protocol reviewed and approved by the UTHSC reviewed and approved by the UTHSC Institutional Review Board, and in accordance Institutional Review Board, and in accordance with the approved protocol.with the approved protocol.

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Mass Casualty IncidentsMass Casualty Incidents

Lack of situational information can make triage and

treatment of trauma patients problematic for civilian trauma centers.

Two killed, five injured in Wharton Co. wreck

Blast at Texas oil refinery kills 14 and injured more than 100 others.

Photo by Elmer Cavender/Special To The Advocate

Image: Brett Coomer/Houston Chronicle/Polaris

ProblemProblem

• Current vital signs monitors in the Current vital signs monitors in the critical care environment suffer from critical care environment suffer from many drawbacksmany drawbacks– ““Dumb” – do not provide actionable Dumb” – do not provide actionable

informationinformation– Big/BulkyBig/Bulky– Do not talk to other systemsDo not talk to other systems– Have many wires Have many wires – Don’t have access to other patient Don’t have access to other patient

information and/or scene datainformation and/or scene data

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Military RelevanceMilitary Relevance

• Prevention of circulatory shock in the battlefield Prevention of circulatory shock in the battlefield requires early recognition and interventions.requires early recognition and interventions.

• Treatment of the combat casualty traditionally Treatment of the combat casualty traditionally has relied on “snap shot” physiologic data has relied on “snap shot” physiologic data points to drive interventions and treatment points to drive interventions and treatment strategies.strategies.

• An intuitive battlefield monitoring device; An intuitive battlefield monitoring device; “smart device” that is capable of supplying the “smart device” that is capable of supplying the medic with constant physiologic observations medic with constant physiologic observations and data would enhance the medic’s ability to and data would enhance the medic’s ability to assess and treat battlefield injuries.assess and treat battlefield injuries.

• Lack of situational information can make triage Lack of situational information can make triage and treatment of trauma patients problematic and treatment of trauma patients problematic for military trauma centers.for military trauma centers.

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Civilian Relevance

• Treatment of the trauma patient may be based on incomplete pre-hospital physiologic data.

• The lack of real-time observable physiologic data and patient progression makes it difficult to accurately predict life saving interventions.

Typical ScenarioTypical Scenario

Critical Areas for Preventable Critical Areas for Preventable DeathsDeaths

Advanced TriageIntelligent DiagnosisDecision SupportWirelessClosed LoopData ManagementMedical Device Interfacing Standards

Problem: Data FlowProblem: Data FlowPatient Information Flow

Stops or is SeverelyReduced Between

Sections

Patient Information Flow Stops or is SeverelyReduced Between

Sections

En Route

Critical Care Tech GapCritical Care Tech Gap

En Route

STANDARD OF CARE

Level IIb:Forward Surgical Team

Level III: Combat Support Hospital

Level IV-V:LandsuhlWalter ReedBAMC

Level I: Point of Injury

En Route

TECH GAP

Casualty Movement

Med

ical

Cap

abili

ty

Athena Wireless Vital Signs Athena Wireless Vital Signs MonitorMonitor

WVSM CapabilitesWVSM Capabilites

• 500 g weight500 g weight• Wireless: 802.11, BluetoothWireless: 802.11, Bluetooth• Waveforms: Waveforms:

– ECGECG– PlethPleth– CO2 (via wireless dongle to Oridion)CO2 (via wireless dongle to Oridion)

• Numerics: Numerics: – HRHR– SpO2SpO2– NIBP (SBP, DBP, MAP)NIBP (SBP, DBP, MAP)– EtCO2 (via wireless dongle to Oridion)EtCO2 (via wireless dongle to Oridion)

Receiving StationReceiving Station

• Current Numeric Vital Signs & Current Numeric Vital Signs & WaveformsWaveforms

• Full trends & projectionsFull trends & projections– Prehospital, EDPrehospital, ED

• Physical ExamPhysical Exam

• ScoresScores

• LSI predictionLSI prediction

• Non linear indices of patient statusNon linear indices of patient status

TRENDSTRENDS

PROJECTIONPROJECTION

PROBABILITY OF PROBABILITY OF NEEDING AN LSINEEDING AN LSI

NON LINEARNON LINEARINDICESINDICES

WVSM ProjectWVSM Project

• Clinical EfficacyClinical Efficacy– Determine the clinical efficacy of using the Athena Wireless Determine the clinical efficacy of using the Athena Wireless

Vital Signs monitor system in a pre-hospital and emergency Vital Signs monitor system in a pre-hospital and emergency room settingroom setting

• Clinical EffectivenessClinical Effectiveness– Determine if the use of this system leads to the use of earlier Determine if the use of this system leads to the use of earlier

life saving interventions in the emergency departmentlife saving interventions in the emergency department

• UsabilityUsability– Determine if this device has better usability characteristics Determine if this device has better usability characteristics

compared to bench mounted vital sign monitors currently compared to bench mounted vital sign monitors currently used in the pre-hospital setting by medical helicopter service used in the pre-hospital setting by medical helicopter service personnelpersonnel

Jose Salinas, PhD

Study DesignStudy Design

• Multi-Center Prospective StudyMulti-Center Prospective Study– UTHealth-Houston/CeTIRUTHealth-Houston/CeTIR

• Memorial Hermann Hospital-TMCMemorial Hermann Hospital-TMC

– U.S. Army Institute of Surgical Research ***U.S. Army Institute of Surgical Research ***• Brooke Army Medical CenterBrooke Army Medical Center

– University of Texas Health Science Center-San Antonio University of Texas Health Science Center-San Antonio ******

• University HospitalUniversity Hospital

• Limited to Air Medical ProvidersLimited to Air Medical Providers– Memorial Hermann Life FlightMemorial Hermann Life Flight– San Antonio AirLifeSan Antonio AirLife

• 18 Month Enrollment Period18 Month Enrollment Period*** Planned

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Study Population

Inclusion Criteria

• > 18 years of age • Trauma Patient• Transported by Memorial

Hermann Life Flight or San Antonio AirLIFE

• Code 2 or Code 3 trauma patients with blunt or penetrating trauma

Exclusion Criteria

• < 18 years of age• Women who present to the ED

who are obviously pregnant• Transported from nursing

home• Actively psychotic • Prisoner (Currently

incarcerated at a correctional facility)

• Not transported by Memorial Hermann Life Flight or San Antonio AirLIFE

Project Setup/TrainingProject Setup/Training

• TrainingTraining– UTHealthUTHealth

• CeTIR CeTIR • Department of Surgery – TraumaDepartment of Surgery – Trauma• Department of Emergency MedicineDepartment of Emergency Medicine

– 80 – Faculty, Residents, Medical Students, Research 80 – Faculty, Residents, Medical Students, Research Coordinators & Research AssociatesCoordinators & Research Associates

– Memorial Hermann HospitalMemorial Hermann Hospital• Memorial Hermann Life FlightMemorial Hermann Life Flight• Emergency DepartmentEmergency Department

– 110 – Flight Nurses, Flight Paramedics, ED Nurses & 110 – Flight Nurses, Flight Paramedics, ED Nurses & Techs.Techs.

Project ExecutionProject Execution

• Equipment DeployedEquipment Deployed

• Simulated WVSM Trial RunsSimulated WVSM Trial Runs– Internal TestingInternal Testing– External TestingExternal Testing

• MHLFMHLF• Full Integration Testing – CeTIR, MHLF & Full Integration Testing – CeTIR, MHLF &

MH-EDMH-ED

• 11stst Subject Enrollment – June 27, Subject Enrollment – June 27, 20112011

WVSM Study Kit EquipmentWVSM Study Kit Equipment

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Pre-Hospital Study ProcessPre-Hospital Study Process

• On scene patient screening & enrollment

• Apply LP-12 monitoring system to patient & WVSM/Oridion monitoring devices to potential study subjects

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Pre-Hospital Study ProcessPre-Hospital Study Process

• Enter Life Saving Interventions on tablet PC:– Intubation– Blood Administration– Chest Tube – Pericardiocentesis– CPR – Chest Decompression

Photo by Ryche Guerrero/JEMS July 2010

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WVSM Patient Arriving Memorial Hermann Hospital

WVSM in RangePatient Assigned to Trauma Bay

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Trauma Bay WVSM DisplayTrauma Bay WVSM Display

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Trauma Center Study ProcessTrauma Center Study Process

• CeTIR research associate responds to the ED for in-bound Code 2 or Code 3 trauma patients.

• Screen and enroll WVSM subject and/or control subject.

– Prospective “real time” data collection.

• Data collection stops when the subject discharge and/or transfer out of the ED

Institutional PartnersInstitutional Partners

Support PartnersSupport Partners

• Athena GTXAthena GTX

• Oridion CapnographyOridion Capnography

• NoninNonin

• State of Texas Emerging State of Texas Emerging Technology FundTechnology Fund

• U.S. Army Combat Casualty Care U.S. Army Combat Casualty Care Research ProgramResearch Program

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AcknowledgementsAcknowledgements

• NTI– Sharon Smith– Monica Phillips

• ISR– Roger Killmer

• UTHSC-Houston (CeTIR)– Charles E. Wade– Jeanette Podbielski– Hari Radhakrishnan– Timothy Welch– Denise Hinds

• Athena GTX, Inc– Mark Darrah– Kevin Stitcher– Joel Meyer