Prospective validation of the Wireless Vital Signs Monitor System

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
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.

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

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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
• Dont 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 medics ability to assess
  and treat battlefield injuries.
• Lack of situational information can make triage
  and treatment of trauma patients problematic 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.

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Typical Scenario
Military Care
Civilian Care
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Typical Scenario (Civilian)
Injury
Pre-hospital
ED/ Trauma Bay
ICU
Transport (Trauma Facility)
OR
Ward
Improved Outcomes
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Typical Scenario (Military)
Injury
ICU
Battlefield
CSH
Transport CCATT
Transport (Nearest)
OR
Ward
Improved Outcomes
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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
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Problem Data Flow
Patient Information Flow Stops or is
Severely Reduced Between Sections
Injury
ICU
Battlefield
CSH
Transport CCATT
Transport (Nearest)
OR
Ward
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Critical Care Tech Gap
Medical Capability
Casualty Movement
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Athena Wireless Vital Signs Monitor
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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)

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Receiving Station

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

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TRENDS
PROJECTION
NON LINEAR INDICES
PROBABILITY OF NEEDING AN LSI
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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
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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
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Study Population

• Inclusion Criteria

• Exclusion Criteria

• gt 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

• lt 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

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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.

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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

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WVSM Study Kit Equipment
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Pre-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 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 Range

• Patient Assigned to Trauma Bay

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Trauma Bay WVSM Display
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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

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Institutional Partners
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Support Partners

• Athena GTX
• Oridion Capnography
• Nonin
• State of Texas Emerging Technology Fund
• U.S. Army Combat Casualty Care Research Program

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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