Abstract
BACKGROUND: Hemorrhagic shock is a leading cause of trauma-related mortality in military and disaster settings, necessitating prompt fluid resuscitation. Conventional infusion methods, which rely on elevating fluid containers to generate hydrostatic pressure, risk secondary injury and are less efficient during prehospital transport. We developed a wearable, portable, sealed positive-pressure infusion device to optimize fluid administration in austere environments. METHODS: Ten male Bama miniature pigs underwent controlled hemorrhagic shock (mean arterial pressure [MAP] < 60 mmHg, induced by blood withdrawal until approximately 40-45% of estimated total blood volume [70 mL/kg body weight] and maintained for 30 min). Animals were randomized to receive resuscitation with 6% hydroxyethyl starch 130/0.4 in saline at 10 mL/min using either the novel device or conventional manual pressure infusion. Vital signs and blood parameters (e.g., activated partial thromboplastin time [APTT]) were measured at baseline, shock phase, 1 h post-resuscitation, and upon completion of resuscitation. Resuscitation time, fluid volume, and maximum infusion line pressure were recorded. RESULTS: All animals achieved successful resuscitation (100% immediate survival). During a 7-day follow-up, one animal in each group died (20%, p > 0.05). The device group exhibited a significantly shorter resuscitation time (103.0 ± 16.97 [95% CI: 81.93, 124.07] vs. 122.4 ± 8.02 [95% CI: 112.44, 132.36] minutes, p = 0.0496) and a higher infusion rate (9.29 ± 0.50 [95% CI: 8.67, 9.91] vs. 7.68 ± 0.40 [95% CI: 7.18, 8.18] mL/min, p < 0.001) compared with the control group. Both groups exhibited reduced APTT post-resuscitation; these descriptive findings may be associated with the colloid used but require further investigation with comprehensive coagulation assays (e.g., viscoelastic testing) and do not imply clinical benefit or harm. CONCLUSION: The portable sealed positive-pressure infusion device provided stable pressure, improved infusion performance, and maintained safety. It represents a feasible solution for managing hemorrhagic shock in prehospital austere settings.