Perforated Concave Earplug (pCEP): A Proof-of-Concept Earplug to Improve Sound Localization without Compromising Noise Attenuation.

Combat soldiers are currently faced with using a hearing-protection device (HPD) at the cost of adequately detecting critical signals impacting mission success. The current study tested the performance of the Perforated-Concave-Earplug (pCEP), a proof-of-concept passive HPD consisting of a concave bowl-like rigid structure attached to a commercial roll-down earplug, designed to improve sound localization with minimal compromising of noise attenuation. Primarily intended for combat/military training settings, our aim was an evaluation of localization of relevant sound sources (single/multiple gunfire, continuous noise, spoken word) compared to 3M™-Combat-Arms™4.1 earplugs in open-mode and 3M™-E-A-R™-Classic™ earplugs. Ninety normal-hearing participants, aged 20-35 years, were asked to localize stimuli delivered from monitors evenly distributed around them in no-HPD and with-HPD conditions. The results showed (1) localization abilities worsened using HPDs; (2) the spoken word was localized less accurately than other stimuli; (3) mean root mean square errors (RMSEs) were largest for stimuli emanating from rear monitors; and (4) localization abilities corresponded to HPD attenuation levels (largest attenuation and mean RMSE: 3M™-E-A-R™-Classic™; smallest attenuation and mean RMSE: 3M™-Combat-Arms™4.1; pCEP was mid-range on both). These findings suggest that the pCEP may benefit in military settings by providing improved sound localization relative to 3M™ E-A-R™-Classic™ and higher attenuation relative to 3M™-Combat Arms™-4.1, recommending its use in noisy environments.

Post-expiry stability of freeze-dried plasma under field conditions - Can shelf life be extended?

BACKGROUND: This prospective study evaluated the effect of routine, uncontrolled, Israeli field storage conditions on the safety and efficacy of Lyo-Plas N Freeze-Dried Plasma (FDP) at the end of the manufacturer's shelf life, and up to 24 months post expiry. Clotting factors V, VIII and XI, proteins S, C, fibrinogen, PTT, ATIII, VWF, and INR as well as TEG, DDM, residual moisture, pH, and sterility of FDP returned from field units after uncontrolled storage were evaluated. STUDY DESIGN AND METHODS: Parameters measured at the end of manufacturer shelf life, as well as 6, 12, 18, and 24 months after expiry, were compared to those of freshly supplied FDP doses. RESULTS: Changes were found when comparing freshly supplied FDP to all field-stored groups in INR, PT, PTT, pH, fibrinogen, and factor VIII. A significant change was also seen in Factor XI in the 12, 18, and 24 months post-expiry samples, Factor V and R in the 24 months post-expiry samples, MA in the 12, 24 months post-expiry group, and Protein C in the 18 months post-expiry group. An increase in the residual moisture from 0.90% in freshly supplied FDP to 1.35% in 24 months post-expiry FDP.; all p < .05. No growth was found in sterility analysis. CONCLUSION: Despite uncontrolled field storage conditions, the findings demonstrate that the safety and efficacy of FDP units, stored in uncontrolled conditions are only slightly affected, even beyond their expiration date. This information allows consideration of possibly extending the shelf life.

Novel self-fixation chest drain device tested in a swine model of pneumo-hemothorax.

INTRODUCTION: Thoracic injuries account for 20-25% of trauma-related deaths. In cases of pneumothorax the insertion of a chest tube is mandatory but associated with high complication rates particularly when inserted under difficult conditions. The C-Lant is a novel chest-tube insertion device that provides integrated double fixation capabilities and can be used by responders with minimal experience. The aim of the study was to test the device in a large animal model. MATERIAL AND METHODS: Pneumothorax, tension pneumothorax, and hemothorax were induced in four white domestic female pigs. The C-Lant device (Vigor Medical Technologies, Haifa, Israel) was inserted as any chest-drain to decompress the thorax. Pull test was applied to test the strength of device fixation. RESULTS: The insertion of the device was simple and effective without detectable negative physiological effects. Reliable fixation was achieved without difficulty. Air and liquid were promptly drained from the chest cavity. Minimal tissue laceration occurred when applying the device in a scenario of erroneous pneumothorax diagnosis with fully expanded lungs. Interconnection with other surgical accessories was smooth. CONCLUSION: The C-Lant is a novel device that facilitates easy insertion and fixation of chest-tubes by minimally experienced medical providers and reduces the likelihood of unwanted expulsion. Clinical studies are planned.

Remote ischemic preconditioning improves tissue oxygenation in a porcine model of controlled hemorrhage without fluid resuscitation.

Remote ischemic preconditioning (RIPC) involves deliberate, brief interruptions of blood flow to increase the tolerance of distant critical organs to ischemia. This study tests the effects of limb RIPC in a porcine model of controlled hemorrhage without replacement therapy simulating an extreme field situation of delayed evacuation to definitive care. Twenty-eight pigs (47 ± 6 kg) were assigned to: (1) control, no procedure (n = 7); (2) HS = hemorrhagic shock (n = 13); and (3) RIPC + HS = remote ischemic preconditioning followed by hemorrhage (n = 8). The animals were observed for 7 h after bleeding without fluid replacement. Survival rate between animals of the RIPC + HS group and those of the HS group were similar (HS, 6 of 13[46%]-vs-RIPC + HS, 4 of 8[50%], p = 0.86 by Chi-square). Animals of the RIPC + HS group had faster recovery of mean arterial pressure and developed higher heart rates without complications. They also had less decrease in pH and bicarbonate, and the increase in lactate began later. Global oxygen delivery was higher, and tissue oxygen extraction ratio lower, in RIPC + HS animals. These improvements after RIPC in hemodynamic and metabolic status provide essential substrates for improved cellular response after hemorrhage and reduction of the likelihood of potentially catastrophic consequences of the accompanying ischemia.

Wireless, non-invasive, wearable device for continuous remote monitoring of hemodynamic parameters in a swine model of controlled hemorrhagic shock.

Accurate and continuous monitoring of critically ill patients is frequently achieved using invasive catheters, which is technically complex. Our purpose was to evaluate the validity and accuracy of a photoplethysmography (PPG)-based remote monitoring device compared to invasive methods of arterial line (AL) and Swan-Ganz (SG) catheters in a swine model of controlled hemorrhagic shock. Following a baseline phase, hemorrhagic shock was induced in 11 pigs by bleeding 35% of their blood volume, followed by a post-bleeding follow-up phase. Animals were monitored concomitantly by the PPG device, an AL and a SG catheter, for a median period of 447 min. Heart rate (HR), systolic and diastolic blood pressure (SBP and DBP, respectively), and cardiac output (CO) were recorded continuously. The complete data set consisted of 1312 paired observations. Correlations between the PPG-based technique and the invasive methods were significant (p < 0.001) during baseline, bleeding and follow-up phases for HR (r = 0.90-0.98), SBP (r = 0.90-0.94), DBP (r = 0.89-0.93), and CO (r = 0.76-0.90). Intraclass correlations for all phases combined were 0.96, 0.92, 0.93 and 0.87 for HR, SBP, DBP and CO, respectively. Correlations for changes in CO, SBP and DBP were significant (p < 0.001) and strong (r > 0.88), with concordance rates (determined by quadrant plots) of 86%, 66% and 68%, respectively. The novel PPG-based device was accurate and valid compared to existing invasive techniques and might be used for continuous monitoring in several clinical settings following further studies.

A Simple Cardiovascular Model for the Study of Hemorrhagic Shock.

Hemorrhagic shock is the number one cause of death on the battlefield and in civilian trauma as well. Mathematical modeling has been applied in this context for decades; however, the formulation of a satisfactory model that is both practical and effective has yet to be achieved. This paper introduces an upgraded version of the 2007 Zenker model for hemorrhagic shock termed the ZenCur model that allows for a better description of the time course of relevant observations. Our study provides a simple but realistic mathematical description of cardiovascular dynamics that may be useful in the assessment and prognosis of hemorrhagic shock. This model is capable of replicating the changes in mean arterial pressure, heart rate, and cardiac output after the onset of bleeding (as observed in four experimental laboratory animals) and achieves a reasonable compromise between an overly detailed depiction of relevant mechanisms, on the one hand, and model simplicity, on the other. The former would require considerable simulations and entail burdensome interpretations. From a clinical standpoint, the goals of the new model are to predict survival and optimize the timing of therapy, in both civilian and military scenarios.

Assessing the Current Generation of Tourniquets.

INTRODUCTION: Tourniquet application is an urgent life-saving procedure. Previous studies demonstrated several drawbacks in tourniquet design and application methods that limit their efficacy; among them, loose application of the device before windlass twisting is a main pitfall. A new generation of modern combat tourniquets was developed to overcome these pitfalls. The objective of this study was to assess the effectiveness of three new tourniquet designs: the CAT Generation 7 (CAT7), the SAM Extremity Tourniquet (SAM-XT), and the SOF Tactical Tourniquet Wide (SOFTT-W) as well as its correlation to the degree of slack. MATERIALS AND METHODS: The three tourniquet models were applied in a randomized sequence on a HapMed leg tourniquet trainer, simulating an above-the-knee traumatic amputation by 60 military medicine track cadets. Applied pressure, hemorrhage control status, time until the bleeding stopped, estimated blood volume loss, and slack were measured. RESULTS: The mean (±SD) pressure applied using the SAM-XT (186 mmHg ±63) or the CAT7 (175 mmHg ±79) was significantly higher compared to the pressure applied by the SOFTT-W (104 mmHg ±101, P < 0.017), with no significant difference between the first two (P > 0.05). Hemorrhage control rate was similar (P > 0.05) with SAM-XT (73.3%) and CAT7 (67.7%), and both were significantly better than the SOFTT-W (35%, P < 0.017). Slack was similar between CAT7 and SAM-XT (5.2 mm ± 3.4 vs. 5 mm ± 3.5, P > 0.05), yet significantly lower compared to the SOFTT-W (9 mm ± 5, P < 0.017). A strong negative correlation was found between slack and hemorrhage control rate (3.2 mm ± 1.5 mm in success vs. 10.5 mm ± 3.4 mm in failure, P < 0.001) and applied pressure (Pearson's correlation coefficient of -0.83, P < 0.001). CONCLUSIONS: Both SAM-XT and CAT7 demonstrated a better pressure profile and hemorrhage control rate compared to SOFTT-W, with no significant difference between the two. The better outcome measures were strongly correlated to less slack.

Assessment of the Efficacy and Safety of a Novel, Low-Cost, Junctional Tourniquet in a Porcine Model of Hemorrhagic Shock.

INTRODUCTION: Commercially available junctional tourniquets (JTQs) have several drawbacks. We developed a low-cost, compact, easy to apply JTQ. The aim of this study was to assess the tourniquets' safety and efficacy in a swine model of controlled hemorrhage. MATERIALS AND METHODS: Five pigs were subjected to controlled bleeding of 35% of their blood volume. Subsequently, the JTQ was applied to the inguinal area for 180 minutes. Afterwards, the tourniquet was removed for additional 60 minutes of follow up. During the study, blood flow to both hind limbs and blood samples for tissue damage markers were repeatedly assessed. Following sacrifice, injury to both inguinal areas was evaluated microscopically and macroscopically. RESULTS: Angiography demonstrated complete occlusion of femoral artery flow, which was restored following removal of the tourniquet. No gross signs of tissue damage were noticed. Histological analysis revealed mild necrosis and infiltration of inflammatory cells. Blood tests showed a mild increase in potassium and lactic acid levels throughout the protocol. CONCLUSIONS: The tourniquet achieved effective arterial occlusion with minimal tissue damage, similar to reports of other JTQs. Subjected to further human trials, the tourniquet might be a suitable candidate for widespread frontline deployment because of its versatility, compactness, and affordable design.

Early Maladaptive Cardiovascular Responses are Associated with Mortality in a Porcine Model of Hemorrhagic Shock.

BACKGROUND: Hemorrhage is a leading cause of death on the battlefield. Current methods for predicting hemodynamic deterioration during hemorrhage are of limited accuracy and practicality. During a study of the effects of remote ischemic preconditioning in pigs that underwent hemorrhage, we noticed arrhythmias among all pigs that died before the end of the experiment but not among surviving pigs. The present study was designed to identify and characterize the early maladaptive hemodynamic responses (tachycardia in the presence of hypotension without a corresponding increase in cardiac index or mean arterial blood pressure) and their predictive power for early mortality in this experimental model. METHODS: Controlled hemorrhagic shock was induced in 16 pigs. Hemodynamic parameters were monitored continuously for 7 h following bleeding. Changes in cardiovascular and laboratory parameters were analyzed and compared between those that had arrhythmia and those that did not. RESULTS: All animals had similar changes in parameters until the end of the bleeding phase. Six animals developed arrhythmias and died early, while 10 had no arrhythmias and survived longer than 6 h or until euthanasia. Unlike survivors, those that died did not compensate for cardiac output (CO), diastolic blood pressure (DBP), and stroke volume (SV). Oxygen delivery (DO2) and mixed venous saturation (SvO2) remained low in animals that had arrhythmia, while achieving certain measures of recuperation in animals that did not. Serum lactate increased earlier and continued to rise in all animals that developed arrhythmias. No significant differences in hemoglobin concentrations were observed between groups. CONCLUSIONS: Despite similar initial changes in variables, we found that low CO, DBP, SV, DO2, SvO2, and high lactate are predictive of death in this animal model. The results of this experimental study suggest that maladaptive responses across a range of cardiovascular parameters that begin early after hemorrhage may be predictive of impending death, particularly in situations where early resuscitative treatment may be delayed.

The approximated cardiovascular reserve index complies with haemorrhage related hemodynamic deterioration pattern: A swine exsanguination model.

BACKGROUND: To estimate the cardiovascular reserve we formulated the Cardiovascular Reserve Index (CVRI) based on physiological measurements. The aim of this study was to evaluate the pattern of CVRI in haemorrhage-related haemodynamic deterioration in an animal model simulating combat injury. METHODS: Data were collected retrospectively from a research database of swine exsanguination model in which serial physiological measurements were made under anesthesia in 12 swine of haemorrhagic injury and 5 controls. We calculated the approximated CVRI (CVRIA). The course of haemodynamic deterioration was defined according to the cumulative blood loss until shock. The ability of heart rate (HR), mean arterial blood pressure (MABP), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) and the CVRIA to predict haemodynamic deterioration was evaluated according to three criteria: strength of association with the course of haemodynamic deterioration (r2 > 0.5); threshold for haemodynamic deterioration detection; and range at which the parameter remained consistently monotonous course of deterioration. RESULTS: Three parameters met the first criterion for prediction of haemodynamic deterioration: HR (r2 = 0.59), SV (r2 = 0.57) and CVRIA (r2 = 0.66). Results were negative for MABP (r2 = 0.27), CO (r2 = 0.33) and SVR (r2 = 0.02). The detection threshold of the CVRIA was 200-300 ml blood loss whereas HR, SV and CO showed a delay in detection, MABP and CVRI exhibited a wide indicative range toward shock. CONCLUSIONS: The CVRIA met preset criteria of a potential predictor of haemorrhage-related haemodynamic deterioration. Prospective studies are required to evaluate use of the CVRI in combat medicine. LEVEL OF EVIDENCE: Level III.