VALIDATION OF AN INEXPENSIVE B-MODE ULTRASOUND DEVICE FOR DETECTION OF DEEP-VEIN THROMBOSIS

Objective: To validate a portable, inexpensive, real-time, B-mode ultr asound device compared with duplex ultrasound in the detection of prox imal lower extremity deep vein thrombosis in hospitalized patients cli nically suspected of having deep vein thrombosis. Design: Prospective cohort study. Setting: Tertiary care community teaching hospital. Pati ents: Medical-surgical hospitalized patients undergoing duplex ultraso nography for clinically suspected lower extremity deep vein thrombosis . Interventions: Hospitalized patients who underwent duplex ultrasound examinations were enrolled in the study. Blinded from the duplex ultr asound results, the investigators utilized the study ultrasound device to perform compression ultrasonography of the common femoral, superfi cial femoral, and popliteal veins within 48 h of the duplex examinatio ns. The results of the study ultrasound device were recorded as normal (compressible) or abnormal (noncompressible). Results: Of the 198 low er limbs evaluated, duplex ultrasonography documented 34 proximal lowe r extremity deep vein thrombi. The study ultrasound device detected 32 of the 34 proximal thrombi detected by duplex ultrasonography. One fa lse-positive result of an examination occurred with the study ultrasou nd device. Compared with duplex ultrasonography, the study ultrasound device had a sensitivity of 94%, specificity of 99%, positive predicti ve value of 97%, and negative predictive value of 98%. Conclusions: Th e results of this investigation document that the study ultrasound dev ice has an acceptable sensitivity specificity and diagnostic accuracy for clinical use in detection of proximal lower extremity deep vein th rombosis. Further evaluation and validation of this ultrasound device are warranted.