Integrated Diagnostic and Treatment Devices for Enroute Critical Care of Patients within Theater

The combination of far-forward surgical hospitals, which vastly shorten time between injury and life-saving surgery, and employment of damage control surgery/resuscitation practices have been significant factors in the much improved survival rates observed during Operations Enduring and Iraqi Freedom as evidenced by the roughly 40% reduction in case fatality rate observed for OEF and OIF over the 2001-2005 period compared to that of the Viet Nam conflict. Post-operative patients coming out of these forward surgical hospitals are often moved within just a few hours following surgery and require high acuity care during transport. These patients are stabilized, but not necessarily stable, and are particularly vulnerable during Interfacility transport between theater hospitals, i.e., between Role 2 and Role 3 facilities or between Role 3 facilities. Interfacility transport of critical patients in theater normally takes place on US Army rotary-wing aircraft, but ground ambulances or even watercraft may be used if necessary. To help ensure positive patient outcomes during these transport missions the originating theater hospital provides an appropriately skilled critical care provider and medical equipment to support the patient during transport. The medical devices provided are the same portable patient monitor and therapeutic devices used in the originating hospital. Use of multiple portable medical devices during Interfacility transport of critical patients is problematic, especially in the rotary-wing environment, which is characterized by high noise levels, extreme vibration, confined space, and low-to-no-light conditions all of which impede patient assessment and prompt intervention. This is troublesome as several adverse events can occur during transport including exsanguination, hypotension, hypoxemia, accidental extubation or loss of intravenous access, inadequate sedation / analgesia, hypothermia, and ventilator malfunction. Furthermore, portable medical devices must be attached to the litter or airframe prior to flight. The practice of distributing medical devices on and around the patient creates a considerable burden for both patient and providers. Use of multiple medical devices also poses significant logistical burdens due to the need to satisfy the various power and maintenance requirements of the individual pieces of equipment, including the need for multiple types of batteries. Therefore, use of an integrated critical care device providing both patient monitoring and therapeutic interventions would aid in overcoming these shortcomings. For several years, the US Army, in collaboration with industry partners and the other services, has been involved in the development of integrated critical care devices that are small, rugged, lightweight, and able to attach to the litter without obstructing patient access. At present the United States Army Medical Materiel Agency is evaluating three such devices the LS-1 developed by Integrated Medical Systems, Inc., the Lightweight Trauma Module developed by Impact Instrumentation, Inc., and the MOVES developed by Thornhill Research, Inc. These devices provide advanced critical care monitoring and ventilator capabilities. Each possesses the ability to accept, control and/or power other devices such as infusion pumps. The MOVES Report Documentation Page Form Approved OMB No. 0704-0188 Public reporting burden for the collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to a penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. 1. REPORT DATE APR 2010 2. REPORT TYPE N/A 3. DATES COVERED 4. TITLE AND SUBTITLE Integrated Diagnostic and Treatment Devices for Enroute Critical Care of Patients within Theater 5a. CONTRACT NUMBER