Early detection of oliguric events in critically ill patients in the ICU with a novel continuous urine flow measurement device: results of an initial validation study

Objectives: Urine output is used to evaluate fluid status and is an important marker for acute kidney injury (AKI). Our primary aim was to validate a new automatic urine output monitoring device by comparison to the current practice – the standard urometer. Methods: We conducted a prospective observational study in three ICUs. Urine flow measurements by Serenno Medical Automatic urine output measuring device (Serenno Medical, Yokneam, Israel) were compared to standard urometer readings taken automatically at 5-minutes intervals by a camera, and to hourly urometer readings by the nurses, both over 1 to 7 days. Our primary outcome was the difference between urine flow assessed by the Serenno device and reference camera-derived measurements (Camera). Our secondary outcome was the difference between urine flow assessed by the Serenno device and hourly nursing assessments (Nurse), and detection of oliguria. Results: Thirty-seven patients completed the study, with 1,306 h of recording and a median of 25 measurement hours per patient. Bland and Altman analysis comparing the study device to camera measurements demonstrated good agreement, with a bias of -0.4 ml/h and 95% confidence intervals ranging from − 28 to 27ml/h. Concordance was 92%. The correlation between Camera and hourly nursing assessment of urine output was distinctly worse with a bias of 7.2 ml and limits of agreement extending from − 75 to + 107 ml. Severe oliguria (urine output < 0.3 ml/kg/h) lasting 2 h or more was common and observed in 8 (21%) of patients. Among the severe oliguric events lasting more than 3 consecutive hours, 6 (41%) were not detected or documented by the nursing staff. There were no device-related complications. Conclusion: The Serenno Medical Automatic urine output measuring device required minimal supervision, little ICU nursing staff attention, and is sufficiently accurate and precise. In addition to providing continuous assessments of urine output, it was considerably more accurate than hourly nursing assessments. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10877-023-00991-w.