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Prospective validation of the Wireless Vital Signs Monitor System

Prospective validation of the Wireless Vital Signs Monitor System. José Salinas, PhD 1 John B. Holcomb, MD 2 1 U.S. Army Institute of Surgical Research, Fort Sam Houston, TX 2 University of Texas Health Science Center, Houston, TX. Disclaimer.

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Prospective validation of the Wireless Vital Signs Monitor System

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  1. Prospective validation of the Wireless Vital Signs Monitor System José Salinas, PhD1 John B. Holcomb, MD2 1U.S. Army Institute of Surgical Research, Fort Sam Houston, TX 2University of Texas Health Science Center, Houston, TX

  2. Disclaimer • The opinions and assertions contained herein are the private views of the author and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense. • This study was conducted under a protocol reviewed and approved by the UTHSC Institutional Review Board, and in accordance with the approved protocol.

  3. Mass Casualty Incidents Lack of situational information can make triage and treatment of trauma patients problematic for civilian trauma centers. Photo by Elmer Cavender/Special To The Advocate Two killed, five injured in Wharton Co. wreck Image: Brett Coomer/Houston Chronicle/Polaris Blast at Texas oil refinery kills 14 and injured more than 100 others.

  4. Problem • Current vital signs monitors in the critical care environment suffer from many drawbacks • “Dumb” – do not provide actionable information • Big/Bulky • Do not talk to other systems • Have many wires • Don’t have access to other patient information and/or scene data

  5. Military Relevance Prevention of circulatory shock in the battlefield requires early recognition and interventions. Treatment of the combat casualty traditionally has relied on “snap shot” physiologic data points to drive interventions and treatment strategies. An intuitive battlefield monitoring device; “smart device” that is capable of supplying the medic with constant physiologic observations and data would enhance the medic’s ability to assess and treat battlefield injuries. Lack of situational information can make triage and treatment of trauma patients problematic for military trauma centers.

  6. 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.

  7. Typical Scenario Military Care Civilian Care

  8. Critical Areas for Preventable Deaths Injury Battlefield Pre-hospital Areas for Research • Advanced Triage • Intelligent Diagnosis • Decision Support • Wireless • Closed Loop • Data Management • Medical Device Interfacing Standards Transport (Nearest) Transport (Trauma Facility) Military Civilian CSH ED/ Trauma Bay

  9. Problem: Data Flow Patient Information Flow Stops or is Severely Reduced Between Sections Injury ICU Battlefield CSH Transport CCATT Transport (Nearest) OR Ward

  10. Critical Care Tech Gap STANDARD OF CARE TECH GAP Level IV-V: Landsuhl Walter Reed BAMC Medical Capability Level III: Combat Support Hospital En Route En Route Level IIb: Forward Surgical Team En Route Level I: Point of Injury Casualty Movement

  11. Athena Wireless Vital Signs Monitor

  12. WVSM Capabilites • 500 g weight • Wireless: 802.11, Bluetooth • Waveforms: • ECG • Pleth • CO2 (via wireless dongle to Oridion) • Numerics: • HR • SpO2 • NIBP (SBP, DBP, MAP) • EtCO2 (via wireless dongle to Oridion)

  13. Receiving Station • Current Numeric Vital Signs & Waveforms • Full trends & projections • Prehospital, ED • Physical Exam • Scores • LSI prediction • Non linear indices of patient status

  14. TRENDS PROJECTION NON LINEAR INDICES PROBABILITY OF NEEDING AN LSI

  15. WVSM Project • Clinical Efficacy • Determine the clinical efficacy of using the Athena Wireless Vital Signs monitor system in a pre-hospital and emergency room setting • Clinical Effectiveness • Determine if the use of this system leads to the use of earlier life saving interventions in the emergency department • Usability • Determine if this device has better usability characteristics compared to bench mounted vital sign monitors currently used in the pre-hospital setting by medical helicopter service personnel Jose Salinas, PhD

  16. Study Design • Multi-Center Prospective Study • UTHealth-Houston/CeTIR • Memorial Hermann Hospital-TMC • U.S. Army Institute of Surgical Research *** • Brooke Army Medical Center • University of Texas Health Science Center-San Antonio *** • University Hospital • Limited to Air Medical Providers • Memorial Hermann Life Flight • San Antonio AirLife • 18 Month Enrollment Period *** Planned

  17. Study Population Inclusion Criteria 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 • > 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

  18. Project Setup/Training • Training • UTHealth • CeTIR • Department of Surgery – Trauma • Department of Emergency Medicine • 80 – Faculty, Residents, Medical Students, Research Coordinators & Research Associates • Memorial Hermann Hospital • Memorial Hermann Life Flight • Emergency Department • 110 – Flight Nurses, Flight Paramedics, ED Nurses & Techs.

  19. Project Execution • Equipment Deployed • Simulated WVSM Trial Runs • Internal Testing • External Testing • MHLF • Full Integration Testing – CeTIR, MHLF & MH-ED • 1st Subject Enrollment – June 27, 2011

  20. WVSM Study Kit Equipment

  21. Pre-Hospital Study Process • On scene patient screening & enrollment • Apply LP-12 monitoring system to patient & WVSM/Oridion monitoring devices to potential study subjects

  22. Pre-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

  23. WVSM Patient Arriving Memorial Hermann Hospital WVSM in Range Patient Assigned to Trauma Bay

  24. Trauma Bay WVSM Display

  25. Trauma 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

  26. Institutional Partners

  27. Support Partners • Athena GTX • OridionCapnography • Nonin • State of Texas Emerging Technology Fund • U.S. Army Combat Casualty Care Research Program

  28. Acknowledgements • 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

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