A Portable Closed-Loop Fluid Resuscitation System to Promote Critical Care and Warfighter Survivability in the Prolonged Field Care Environment
Abstract
Objectives and Rationale: On the battlefield, injury resulting in hemorrhage, burns, or dehydration requires precise patient assessment and stabilization to promote survivability. Current care under fire guidelines suggest intermittent monitoring of patients using blood pressure, heart rate, and pulse oximetry. While these vitals are important in understanding a patient s condition, there are substantial limitations including the potential for masking the true physiological state, the requirement of multiple cumbersome diagnostic tools, the constraint in frequency of assessment, and the requirement for manual titration of fluid that may result in human error leading to suboptimal outcomes. We have developed Medix, a portable, minimally invasive and rugged system that has the ability to continuously monitor vital parameters (urine output, intra-abdominal pressure, relative stroke volume, respiratory rate, heart rate, and temperature), alert medics to patient deterioration, and stabilize wounded Warfighters via closed-loop fluid therapy. Medix will significantly impact far-forward critical care by (1) providing continuity of care for prolonged pre-hospital care or multiple transfers, (2) enhancing assessment abilities, (3) enabling the care of multiple casualties, and (4) providing a resource to conserve medic capability and provide respite. Hypothesis/Objectives: Our central hypothesis of this grant is that the Medix device is sensitive and reliable in the measurement of vital parameters that will provide early actionable data for medic assessment and casualty stabilization. The primary objective of this grant is to aggregate and analyze all data collected (30 animals and 75 trauma patients), to develop and finalize machine learning algorithms for (a) decision support for early detection of actionable information and (b) closed-loop resuscitation. Secondary objectives will be conducted in both preclinical and clinical settings and include: (1) validate Medix sensitivity in detection of physiological changes indicating patient deterioration; (2) verify utility in urine output- and intra-abdominal pressure-based guidance in fluid resuscitation; and (3) validate enhanced stabilization outcomes using Medix data compared to current standards. Project Significance and Impact: We have designed Medix to meet the requirement of Focus Area 2. Medix is the next-generation monitoring and stabilization system for Soldiers who may sustain prolonged out of hospital care in far-forward situations or endure long transfer times. The ultimate goal of the Medix system is to provide the best critical care for our wounded Soldiers with both ease of use and minimal intervention required for the critical care team. The long-term impact of the studies conducted in this grant will be the development and validation of an autonomous, urinary-catheter-based closed loop system that will offer the best possible continuity of care for Soldiers wounded on the battlefield. Not only do we anticipate that the Medix system will be the most sensitive and precise with detection of the physiological state of the wounded Soldier, but it will enable both continuous care for the patient from pre-hospital and en route until arrival at the intensive care unit (ICU) and personalized and optimal resuscitation based on robust and rapid indicators of volemic state. The studies proposed in this grant will enable TheraNova to further develop and refine Medix, a highly sensitive monitoring system with intentions of autonomous patient assessment and stabilization capabilities for far-forward applications. Specifically, these studies will provide device validation for sensitivity and accuracy in detection of patient deterioration and identification of patients requiring blood product resuscitation and optimized fluid resuscitation procedures. Furthermore, the data obtained from this grant (30 swine and 75 trauma patients) will be used to establish the neces
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1710554
Entities
People
- Daniel Burnett
Organizations
- United States Army