A Real-Time, Non-Invasive Monitoring System to Guide Accurate Fluid Resuscitation of Combat Casualties During Pre-Hospital and Transport Medical Care

Trauma related hemorrhage is a leading cause of preventable death on the battlefield. This project addresses the problem of monitoring and guidance for optimal fluid resuscitation for hemorrhage in pre-hospital and transport settings. The proposed Phase II work will deliver a CipherOx Resuscitation Monitor (CRM) ready for clinical trials for an FDA 510K submission. The CRM is a noninvasive, small, portable device that uses a pulse oximeter based finger sensor and is capable of heartbeat-to-heartbeat 1) assessment of the effectiveness of fluid resuscitation in a bleeding or a potentially bleeding patient; and, 2) estimation of how much volume blood return a patient requires to prevent over or under resuscitation. In addition, the CRM will have the capacity of storing up to two years of continuous data and be capable of transmitting resuscitation information wirelessly to a tablet, laptop and/or workstation. This provides the ability to maintain data continuity throughout the treatment of injured warfighters from the point of injury to higher echelons of care. The CRM device will be extensively tested and validated during human trials including a) lower body negative pressure hemorrhage and resuscitation studies, b) exercise studies, and c) 1 liter hemorrhage and resuscitation studies.