Randomized clinical trial of point-of-care, limited ultrasonography for trauma in the emergency department: Sonography outcomes assessment program (SOAP)-1 trial

Abstract

Study objectives: More than 38 million people are evaluated for trauma annually; it is the leading cause of death in persons younger than 45 years. According to the "golden hour" paradigm of trauma care, the provision of definitive care for this population is time-critical. Among patients presenting to the emergency department (ED) with suspected torso trauma, the objective of this study was to assess whether using point-of-care, limited ultrasonography (PLUS) for trauma, compared with usual care, decreased time from arrival to operative or interventional radiologic care (OR/IR), computed tomography (CT) and diagnostic peritoneal lavage (DPL) use, ICU and hospital length of stay, and charges. Methods: This randomized clinical trial was conducted at 2 Level I trauma centers. Patients were eligible if on presentation there was clinical suspicion for torso trauma and they did not require immediate transfer to the operating room. Data collected on all patients included demographics, physician, time since injury, vital signs, injury scores, time to OR/IR, CT and DPL use, diagnoses, ICU and hospital days, and charges. All patients were evaluated by a standard protocol. Those randomized to PLUS also received limited, goal-oriented sonography performed by appropriately trained and verified sonographers who were either emergency physicians or trauma surgeons. The salient PLUS results were the presence of free fluid in the peritoneum, pleura, or pericardium. Actions taken according to PLUS results were recorded. Main study outcomes were time to OR/IR, CT and DPL use, ICU and hospital days, and charges. Data analyses were completed on an intention-to-treat basis. Multivariate and hierarchical models were used to control for confounders. Results: Data were collected on 217 patients (123 PLUS and 94 non-PLUS), and all results are reported as mean±95% confidence interval. There were no significant differences in demographics, time since injury, vital signs, and injury scores, or proportions of diagnoses between groups. Minutes to OR/IR were significantly less for PLUS versus non-PLUS patients (57±6 versus 170±21 minutes). Of PLUS patients, 52%±8.8% of patients underwent CT, and 2%±2% had DPL, whereas 85%±4% of non-PLUS patients underwent CT and 20%±5% had DPL, both significantly different. PLUS patients spent significantly fewer days in the hospital (6.2±1.2 versus 10.2±2.7 days). Charges were significantly less for PLUS patients ($16,100±$3,200 versus $31,500±$7,400). All significant differences were maintained in multivariate analyses controlling for institution, time since injury, injury scores, and diagnoses. Using hierarchical modeling to control for physician-to-physician variability, all significant differences were maintained. Conclusion: Trauma patients evaluated with PLUS received definitive care more rapidly than patients not evaluated with sonography (1 versus 3 hours). CT and DPL use were reduced by the addition of PLUS. Days in the hospital were substantially fewer in PLUS-evaluated patients, supporting the "golden hour" paradigm that earlier definitive care leads to better outcomes. Collectively, these factors contributed to $14,100 in average savings per patient. Therefore, the benefits of PLUS are multidimensional, including improved patient care, better ED and hospital resource utilization, and high cost-effectiveness.