Randomized Controlled Clinical Trial of Point-of-Care, Limited Ultrasonography for Trauma in the Emergency Department: The First Sonography Outcomes Assessment Program Trial

Abstract

Annually, 38 million people are evaluated for trauma, the leading cause of death in persons younger than 45 years. The primary objective is to assess whether using a protocol inclusive of point-of-care, limited ultrasonography (PLUS), compared to usual care (control), among patients presenting to the emergency department (ED) with suspected torso trauma decreased time to operative care. The study was a randomized controlled clinical trial conducted during a 6-month period at 2 Level I trauma centers. The intervention was PLUS conducted by verified clinician sonographers. The primary outcome measure was time from ED arrival to transfer to operative care; secondary outcomes included computed tomography (CT) use, length of stay, complications, and charges. Regression models controlled for confounders and analyzed physician-to-physician variability. All analyses were conducted on an intention-to-treat basis. Results are presented as mean, first-quartile, median, and third-quartile, with multiplicative change and 95% confidence intervals (CIs), or percentage with odds ratio and 95% CIs. Four hundred forty-four patients with suspected torso trauma were eligible; 136 patients lacked consent, and attending physicians refused enrollment of 46 patients. Two hundred sixty-two patients were enrolled: 135 PLUS patients and 127 controls. There were no important differences between groups. Time to operative care was 64% (48, 76) less for PLUS compared to control patients. PLUS patients underwent fewer CTs (odds ratio 0.16) (0.07, 0.32), spent 27% (1, 46) fewer days in hospital, and had fewer complications (odds ratio 0.16) (0.07, 0.32), and charges were 35% (19, 48) less compared to control. A PLUS-inclusive protocol significantly decreased time to operative care in patients with suspected torso trauma, with improved resource use and lower charges.