Clinical Care
Capability Development Project
Project Plan
Evaluation of Critical Care Monitor Technology
During the U. S. Navy Strong Angel Exercise
April, 2000
CONTENTS....................................................................................................................................................................... 2
1. Introduction.............................................................................................................................................................. 3
2. Goals........................................................................................................................................................................... 3
3. Anticipated
Results................................................................................................................................................. 3
4. Management
Plan..................................................................................................................................................... 3
5. Objectives.................................................................................................................................................................. 4
6. Facilities..................................................................................................................................................................... 4
7. Project
Protocol........................................................................................................................................................ 4
8. Project
Milestones................................................................................................................................................... 7
9. Unique
Benefits of the Strong Angel Exercise to NASA Space Medicine..................................................... 7
10. Non-unique
Benefits of the Strong Angel Exercise to NASA Space Medicine............................................. 8
11. Project
Risk................................................................................................................................................................ 8
12. Strategic
Allies.......................................................................................................................................................... 8
13. List of
Participant Companies................................................................................................................................. 8
PROJECT PLAN:
EVALUATION OF CRITICAL CARE MONITOR TECHNOLOGY DURING THE STRONG ANGEL EXERCISE
The NASA Critical Path Roadmap identifies “trauma and acute
medical problems” as a clinical capability risk category
(http://criticalpath.jsc.nasa.gov).
Specific risks include major trauma,
organ laceration or contusion, hemoperitoneum, pulmonary failure, pneumo-,
hemothorax, burn, open bone fracture, blunt head trauma, and penetrating
injury. Risk mitigation of one or more
of these events includes the capability for critical care monitoring. Currently the ISS Crew Health Care System
(CHeCS) does not provide such a capability.
The Clinical Space Medicine Strategic Planning Forum (4/8/97), sponsored
by NASA Medical Operations, identified the development of trauma care
capabilities as one of the top priorities for Space Medicine. The Clinical Care Capability Development
Project (CCCDP) subsequently undertook the task to address this need.
In January 2000 the NASA Johnson Space Center’s (JSC) Medical Operations Branch (MOB) was invited to participate in the U.S. Navy RIMPAC 2000/Strong Angel exercise in the Hawaiian Islands. This exercise, scheduled for June 2000, will involve seven nations and several public health and disaster response organizations. A key component of this exercise will be the establishment of a 300-person mock refugee camp, to simulate mass dislocation due to conflict or natural disaster. This refugee camp will be connected to the East Carolina University School of Medicine (ECU) via the NASA TDRSS satellite system, which will provide Internet Protocol (IP) connectivity. This setup will be configured to support real-time IP video, Next Generation Internet (NGI), biosensors through telemetry, and store/forward clinical telemedicine applications. The objective is to build a nomadic computing network matrix with links to the seven countries participating in the Strong Angel exercise through the ECU Bridge. The long-term goal is to build a global infrastructure that is NGI compliant and can support clinical needs as part of disaster response in a global environment. Telemedicine communication system evaluation criteria will include frame-rate loss, video degradation, audio dropouts, audio/video synchronization, and data retransmissions. The telemedicine application will provide the inputs to the IP CODEC. The CODEC will connect to the Ethernet router and hub. The network management protocol will be TCP/IP. Further information can be found at: http://www.quasar.org/memes/intellimedcom/RIMPAC2000-Strong-Angel-brief.htm
The opportunities afforded by this simulation exercise, reviewed by CCCDP, were deemed highly compatible with the NASA/JSC MOB interest in evaluating critical care physiological monitoring systems. The following is a proposal for CCCDP to perform a trade study within the context of the Strong Angel exercise to evaluate the current state of the art in the critical care monitor market and identify products, traits and capabilities consistent with requirements for future space medical systems.
The findings from this activity will be beneficial to both the military and NASA who have parallel challenges in delivering medical care to remote personnel (i.e. soldiers in the field and astronauts during space flight). The exercise will also be beneficial to public health and disaster response organizations in assessing potential technological solutions for rapid response to natural or man-made disasters as targeted in the RIMPAC 2000/Strong Angel Exercise.
· Determine the state of the art of critical care monitors
· Develop collaborative relationships and information exchange with medical device manufacturers
· Identify current trends in critical care monitoring clinical communication standards
· Determine the future trends and technologies of critical care monitors
· Define requirements for space mission critical care monitoring capability[1]
· Position NASA Space Medicine so as to influence and participate in the establishment of technical standards for critical care monitoring technology (including standards for communication, interface design, command & control).
· Comprehensive statement on state of the art of critical care monitors (white paper)
· Definition of space mission critical care monitoring capability needs (including care provider skills, technology specs, and appropriate procedures/protocols)
· Identification of discrepancies between state of the art and needs
· Determine status of communication standards for critical care monitoring technology
· Closer working relationship with strategic allies
This project requires the participation of several organizations including NASA Medical Operations, intra- and extramural strategic allies, and a number of industry participants.
The Strong Angel exercise is under the control of the US Navy 3rd Fleet. Management of the telemedicine element of Strong Angel resides with Mr. Dave Balch, East Carolina University (ECU) and Dr. Dave Warner, MindTel.
Management of NASA Medical Operations participation will be handled through CCCDP. CCCDP personnel will:
· Develop the Medical Operations project plan
· Oversee the establishment of the necessary strategic alliances including
NASA JSC Mission Operations Directorate (MOD)
NASA JSC Avionics Systems Division
East Carolina University
· Act as the primary contact with Balch/Warner;
· Act as the primary contact with Industry participants
· Provide support personnel at the field site
· Identify and schedule consultants to be in place at the consultant node during field trials
· Coordinate the acquisition, analysis, and reporting of all data
· Write an “after action” report within 14 days of terminating the field test
· Write a Final Report within 6 months of the field test
· Disseminate information to industry partners as appropriate
ECU will be responsible for establishing field power and communication resources and IP connectivity to ECU. MOD will be responsible for connectivity to ECU and furnishing facilities for consultant node.
Collaborative activities pursued within the scope of this project are intended to satisfy the following short and long-term objectives:
·
Assess potential for
development of remote command and control diagnostic and therapeutic capability
·
Enhance collaboration
between MOD and SA for development of advanced mission support capabilities
·
Participate in a high
visible, international exercise
Hawaii:
The facilities used for setting-up the monitoring equipment will be located inland at the Refugee camp the Big Island of Hawaii. The camp will have a total of 78 tents with one designated as an Experimentation Tent. This is where the NASA MOB hardware will be located. There will be 120 VAC power and a TCP/IP network drop for data communications. The data communications network will be a shared network and will be divided into time slots. There will be two 4 hour slots during the daylight hours and two 8 hour slots during the non-daylight hours. The non-daylight hours will be utilized less, therefore, scheduling time during these periods will be easier. The data communications network will consist of a bi-directional 1Mb TDRSS link between Hawaii and East Carolina University. Other ground segment resources are expected to include:
·
2 Portable ground
stations (full duplex 1.5 mb/s minimum)
·
2 T1 Multiplexors
768kbps Bandwidth to the internet Power source (generator or solar) for remote
operations
·
Wireless 100mbps
network with 5 mile range
·
Ethernet router,
hub, and network cards
East Carolina University:
This facility will act as the “bridge” for forwarding telemedicine data coming from Hawaii. Once the data are received it will be routed to Johnson Space Center via a high speed Internet II connection.
Mission Operations Directorate (MOD) consultant node:
This consultant node will be located at Johnson Space Center in building 30 in either the Exploration Planning and Operations Center (ExPOC) or the Qualification and Utilization of Electronic System Technology (QUEST) lab. Availability, suitability, and connectivity will determine which facility is used. This site will receive the data from the East Carolina University Bridge and will have a computer workstation set up for viewing and storing the data. CCCDP will configure a workstation with appropriate software and data recording capabilities.
Wyle Laboratories:
The Wyle Laboratories Advanced Projects Lab will be used for the initial evaluation and testing of each of the monitors that have met the requirements for inclusion. Advanced Projects will supply a computer workstation for receiving data sent from the monitors, and NASA JSC Avionics Systems Division will supply a TDRSS communications link simulator. A suite of physiological simulators will be used to evaluate monitor performance in the lab and during field testing.
CCCDP engineers will familiarize themselves with the use and operation of the monitors, accessories, and technical manuals of the systems that meet the requirements for inclusion outlined below. Each monitoring system will be evaluated based on the criteria outlined below. Since all of the systems considered for evaluation have attained FDA 510K compliance or are completing the process, manufacturer’s performance data will be used. Data directly relevant to use in a field environment (i.e. battery runtime, screen view angle etc) will be determined through in-house testing. Subjective human factors data will be evaluated by at least three CCCDP engineers, more if time and staffing allow. Battery runtime will be evaluated (X?) times to determine a mean battery operating time. Throughout the evaluation process, CCCDP will gather information regarding the use, operation, and testing of the monitors from the open literature and government sources.
1. Power:
a. The system shall be able to be powered from either 110VAC at 60Hz or 220VAC at 50Hz.
b. The system shall have a battery back-up capability. This capability shall be integral to the systems’ design and should allow the monitor to operate for 30 or more minutes under most monitoring situations.
c. The battery should recharge by connecting the monitoring system to an external power source and should not require battery removal.
2. Physical:
a. The system shall be portable in nature and be able to withstand a field/transport environment.
b. The system shall weigh no more than 30 pounds.
c. The physical volume shall be no greater than 1 cubic foot.
3. Data:
a. The system shall have the capability to connect to a 10-BaseT Ethernet network.
b. The system shall transfer medical data real time via IP.
4. Medical Monitoring:
a. The system shall be able to acquire a 5-lead electrocardiogram (ECG) at a minimum.
b. The system shall be able to monitor SpO2.
c. The system shall be able to monitor non-invasive blood pressure.
d. The system shall be able to monitor invasive blood pressure.
e. The system shall be able to monitor body temperature.
f. The system shall be able to monitor ETCO2.
Evaluation Criteria:
1. Usability/Human Factors
a. Training requirements
b. User interface configuration
c. Screen viewing angle
d. Time and ease of set-up
e. Maintenance required
f. Documentation usability
g. Additional comments
2. Performance
a. Power requirements
b. Battery runtime
c. Operation/Storage environmental limits
3. Capability and Features
a. Monitored parameter matrix
b. Calculated parameters
c. Data storage
d. Trending
e. Features, i.e. barcode scanning, drug calculations
4. Alarms
5. Cost
6. Military certification, mil spec 810, 421, 422
A system of physiological signal simulators, supplied by BioTek Instruments, Inc., Winooski, VT, will be used to provide the monitors with data. This simulator system is programmable and, thus will be configured to simulate clinical scenarios relevant to projected specific clinical pathologies that may occur on ISS. One example under consideration is a severe burn. Simulation of a specific scenario involving a burn patient will be used to evaluate the capability of the consulting flight surgeon to accurately and reliably diagnose and determine an appropriate course of treatment. The specific details of this protocol will be developed once the simulators are acquired and installed in the Advanced Projects Laboratory.
Working with the manufacturer’s engineers, communication requirements will be determined for digital remote monitoring. Most of the systems will require a gateway computer to be configured to facilitate remote monitoring via TCP/IP, which is the protocol used for TDRSS (Telemetry Data Relay Satellite System) communication. Each monitor, gateway system, and remote-monitoring software package will be tested using calibrated simulators. Simulated telemetry will be used to recreate clinical scenarios relevant to projected clinical pathology. Following operation and familiarization of equipment in a standard configuration, the equipment will be evaluated using a TDRSS simulation network. Remote monitoring will be evaluated with varying delay times. Remote output data will be compared to the calibrated input data to ensure data integrity across the network. This phase of the evaluation will be open to collaboration with the manufacturer’s engineers as the TDRSS simulator offers a unique resource
Evaluation Criteria
1. Remote monitoring
a. Bandwidth required
b. Gateway requirements
i. Hardware
ii. Software
c. Gateway performance
i. Delay tolerance
ii. Data integrity post TDRSS
Operational deploy will involve two CCCDP engineers operating the equipment in the refugee site experiment tent, Hilo, Hawaii. Only those units that successfully demonstrate the ability to function over the TDRSS system will be used in this phase. Each system will be scheduled for a multi-hour satellite-communication link. Data collection will focus on usability and human factors. Units will be run using both external power and battery power. CCCDP personnel will work with the DoD/civilian project coordinators to support equipment and technology demonstrations. A log will be kept to catalog the problems that arise during the deployment. A video record of the environment and operational equipment will be used.
Data will be sent via the TDRSS link to East Carolina University and then to NASA JSC ExPOC or Quest Lab. Data will be collected on videotape and/or digitally for analysis of data integrity. Output data will be compared against the calibrated source signals.
Evaluation Criteria
1. Field operation
a. Influence of lighting, dust, temperature, humidity, etc.
b. Transportability
c. Compatibility with field power supply
2. Usability
a. Ease of setup
b. Screen visibility
c. Battery failure time
3. Remote diagnostic capability
a. Accuracy
b. Reliability
c. Confidence
4. Network performance
a. Data transmission rate
b. Data drop out
c. Impact of loss of signal
d. Error rate
After Action Report:
Immediately following the deployment, an After Action Report will be prepared capturing the results of the field phase as well as lessons learned. It will also present the initial data of the first two phases and will be completed within two weeks of the return from Hilo. The relevant sections of the report will be sent to the critical care monitor vendors to stimulate two-way collaboration regarding the results of the evaluation and future direction of the company regarding critical care monitors.
Flight Surgeon Evaluation:
The goal of this effort is to evaluate the state-of-the-art monitors in the context of space medical care using the flight surgeons’ unique operational experience. Data collected will focus on the applicability of the units as presented, usability of remote interface, and identification of desired functionality and features of a future “ideal” system. Due to time constraints, the NASA flight surgeons will evaluate the critical care monitors after the Strong Angel exercise.
Evaluation Criteria
1. Current Equipment
a. Crew Use
b. Functionality
2. Ideal System
a. Functionality
b. Features
c. Uses; station, X-38, BIO-Plex
Final Report:
Due to the proprietary nature of the information collected in the project, the final report will be issued in two sections. The first section will be an executive summary of the work and the resulting findings. The summary will contain no proprietary information. The second section will contain all of the data and experience collected throughout the evaluation. Distribution of this document will be limited to JSC Medical Operations personnel directly related to selection and development of on-orbit care capabilities.
1. Company Specific Direction of R&D Efforts
a. Willingness, level of support
b. Research and Development Direction
i. Develop systems for telemedical use
ii. Remote control
iii. Wireless sensors
(see Appendix A)
Phase 1, Project Planning & Equipment Acquisition, Begins March 1, 2000
Phase 2, Monitor in-house Testing, Begins April 20, 2000
Phase 3, Operational Deployment, Begins May 16, 2000
-Begin Testing in Hawaii June 11, 2000
Phase 4, Post Deployment, Begins June 19, 2000
· Provides an opportunity to evaluate medical hardware and procedures in the context of a high-fidelity ISS communication system simulation (TDRSS satcomm; hybrid ground segment using T1 and/or Internet 2 capabilities; multiple routers between sites).
· Joint participation of NASA and US Navy has resulted in significant industry collaborative support
· Unique opportunity to perform comprehensive trade study of critical care monitors using TDRSS delay simulator (utilize as triage to determine which units to take forward to field test).
· Strategic alliance with East Carolina University (http://www.telemed.med.ecu.edu/) – has two specific benefits: 1) cooperation with a leader in the practice of telemedicine in daily healthcare, and 2) cooperation with the recipient of a $4.6 million NIH/NLM award to study the applications of the Next Generation Internet Capabilities for telemedicine.
· Participation in a highly visible, international exercise without being positioned in the critical path (the telemedicine component is an adjunct to the remainder of the RIMPAC 2000/Strong Angel exercise focus on multinational coordination).
· Opportunity to foster strategic alliance with NASA MOD EXPOC and QUEST. A stronger relationship between MOD and Space Medicine leads to the evolution of systems better suited for the performance of space medicine. Near-term benefits included securing MOD/MCC-H support for the implementation of the Comprehensive Medical Information System for ISS mission support. Long-term benefits include the cross-pollination of advanced Mission Control Center (MCC) concepts on the basis of design principles from medical informatics, cognitive engineering, and MOD lessons learned.
· Opportunity to evaluate training and operability of critical care monitoring systems with CMO-equivalent user knowledge in the field
· Opportunity to enhance NASA clinical experience in providing remote diagnostic support
· Opportunity to expand strategic alliance with US Navy medical program
No humans or animals will be used in the conduct of this evaluation. The objectives defined for this effort, determine state of the art and foster a collaborative relation with industry and the military, are inherently attainable. While complete cooperation with the manufacturers is desirable, documentation of vendor support is fundamental to determining partners for the future development of space medical hardware. The phased approach will allow for corrective measures and procedural “fine tuning” that will help ensure successful completion of subsequent phases. Additionally, the progression of data collection will provide personnel with continuous and cumulative training in the use of the monitoring systems as well as the simulator and data collection process. Primary mission failure points will be during deployment, as it is during any operation. Potential failures include; no A/C power, loss of TCP/IP connectivity, equipment damage, and random failures. While CCCDP has no direct control over the field logistics, personnel are working directly with the DoD/civilian project coordinators to ensure adequate infrastructure during the deployment. Random failures will challenge the field engineers and JSC support personnel to develop contingency procedures that will provide valuable lessons for development of on-orbit procedures.
East Carolina University School of Medicine researchers have conducted telemedicine consultations since 1992 and to date have completed over 3,000 consultations in 34 different specialties of medicine over its REACH-TV Network. Supporting telemedicine, distance learning and continuing medical education, the REACH-TV Network is made up of ATM, T1, microwave, ISDN, and POTS (plain old telephone service) communication links spread out over the state of North Carolina. The Telemedicine Center at East Carolina University has received a $4.6 million contract award from the National Institutes of Health and the National Library of Medicine to study applications of the Next Generation Internet Capabilities. The Next Generation Internet will use technologies such as fiber optics to allow more information to be transmitted faster. ECU's telemedicine team will look at how these technologies will benefit telemedicine. Specifically, the Telemedicine Center will evaluate equipment, network reliability and the transmission of large data files, important in specialties such as cardiology. Also studied will be audio fidelity, where subtle changes can significantly alter clinical findings.
The JSC Mission Operations Directorate has two facilities designed for use in support of remote/exploration type activities. The ExPOC is based on the current MCC architecture and is designed to help validate the operations concepts defined in the Operations Concept for the Human Exploration of Mars document (DD-099-05). The QUEST Lab is intended for prototyping revolutionary concepts in information management and remote system/mission support to better understand the technologies that will take the Mission Control Center to the 21st century. MOD has agreed to provide the CCCDP access to one of these facilities in support of Strong Angel. Through participation with this and other projects, the Mission Operations Directorate will develop an understanding of the Mission Control Center infrastructure required to support the Human Exploration of Space. It is also anticipated that through this partnership the CCCDP will be able to prototype command, control and planning systems that will drive the design for future space medical systems.
Agilent
Technologies
Company Description: “Agilent’s healthcare solutions business is a worldwide leader in clinical measurement and diagnostic solutions and holds the leading market share in patient monitoring, cardiovascular ultrasound imaging and critical-care information-management systems”, www.agilent.com.
Bio-Tek
Instruments, Inc.
Company Description: Bio-Tek has been dedicated to the development of biomedical test instrumentation for over 30 years. They will provide use of the Lion Heart 3, Pulse-Ox, and NIBP simulator/testers and the Otis computer interface for system control. www.biotek.com
Datascope Corp.
Company Description: Datascope is a leading manufacturer of patient monitoring devices as well as cardiac care products, www.datascope.com
Datex-Ohmeda
Company Description: Datex-Ohmeda is a medical monitoring device manufacturer that specializes in anesthesia and ventilation monitoring, information management, and critical care monitoring. They are a global company and are a leader in the patient monitoring technology. www.datex-ohmeda.com
Protocol Systems,
Inc.
Company Description:
Protocol develops portable patient monitors that are ruggedized.
Protocol is recognized as the worldwide
market leader for portable patient monitoring and field military monitoring
applications.
Siemens Medical
Systems, Inc.
Company Description: This company is a leading medical device manufacturer and “provides world-leading technology for diagnostic and therapeutic intervention at all stages along the chain.” www.sms.siemens.com
Spacelabs Medical,
Inc.
Company Description: “Spacelabs Medical is a leading provider of integrated healthcare information systems and medical devices. The company has developed leading-edge physiological monitoring and information products for 40 years.”, www.slmd.com They developed some of the first medical hardware used in manned space flight.
[1] This is also relevant to the CCCDP collaboration with the US Army Medical Research & Materiel Command Telemedicine and Advanced Technology Research Center and the Department of Energy Sandia National Laboratories on Inter-operability Standards for Healthcare Systems of the Future. See http://206.39.77.2/standards/index.html for more information.