U.S. Army Institute of Surgical Research
Fort Sam Houston, TX
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
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.
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.
3
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
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.
5
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.
6
Typical Scenario
Critical Areas for Preventable
Deaths
Advanced Triage
Intelligent Diagnosis
Decision Support
Wireless
Closed Loop
Data Management
Medical Device
Interfacing Standards
Problem: Data Flow
Patient Information Flow
Stops or is Severely
Reduced Between
Sections
Critical Care Tech Gap
Medical Capability
STANDARD OF CARE
Level I:
Point of
Injury
Level III:
Combat
Support
En RouteLevel IIb: En Route
En Route
Hospital
Forward
Surgical
Team
Casualty Movement
Level IV-V:
Landsuhl
Walter Reed
BAMC
Athena Wireless Vital Signs
Monitor
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)
Receiving Station
• Current Numeric Vital Signs &
Waveforms
• Full trends & projections
– Prehospital, ED
•
•
•
•
Physical Exam
Scores
LSI prediction
Non linear indices of patient status
TRENDS
PROJECTION
PROBABILITY OF
NEEDING AN LSI
NON LINEAR
INDICES
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 personnelJose Salinas, PhD
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
Study Population
20
Inclusion Criteria
Exclusion 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
• < 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/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.
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
WVSM Study Kit Equipment
Pre-Hospital Study Process
• On scene patient
screening &
enrollment
• Apply LP-12
monitoring system
to patient &
WVSM/Oridion
monitoring devices
to potential study
subjects
24
Pre-Hospital Study Process
• Enter Life Saving
Interventions on tablet
PC:
Photo by Ryche Guerrero/JEMS July 2010
25
–
–
–
–
–
–
Intubation
Blood Administration
Chest Tube
Pericardiocentesis
CPR
Chest Decompression
WVSM Patient Arriving
Memorial Hermann Hospital
WVSM in Range
26
Patient Assigned to
Trauma Bay
Trauma Bay WVSM Display
27
Trauma Center Study Process
• CeTIR research associate
responds to the ED for inbound 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
28
Institutional Partners
Support Partners
•
•
•
•
Athena GTX
Oridion Capnography
Nonin
State of Texas Emerging
Technology Fund
• U.S. Army Combat Casualty Care
Research Program
Acknowledgements
• NTI
– Sharon Smith
– Monica Phillips
• ISR
– Roger Killmer
• UTHSC-Houston
(CeTIR)
–
–
–
–
–
31
Charles E. Wade
Jeanette Podbielski
Hari Radhakrishnan
Timothy Welch
Denise Hinds
• Athena GTX, Inc
– Mark Darrah
– Kevin Stitcher
– Joel Meyer