Assessment of Intra-Abdominal Pressure with a Novel Continuous Bladder Pressure Monitor-A Clinical Validation Study

Life (Basel). 2023 Jan 30;13(2):384. doi: 10.3390/life13020384.

Abstract

Introduction: Intra-abdominal hypertension and the resulting abdominal compartment syndrome are serious complications of severely ill patients. Diagnosis requires an intra-abdominal pressure (IAP) measurement, which is currently cumbersome and underused. We aimed to test the accuracy of a novel continuous IAP monitor.

Methods: Adults having laparoscopic surgery and requiring urinary catheter intra-operatively were recruited to this single-arm validation study. IAP measurements using the novel monitor and a gold-standard foley manometer were compared. After anesthesia induction, a pneumoperitoneum was induced through a laparoscopic insufflator, and five randomly pre-defined pressures (between 5 and 25 mmHg) were achieved and simultaneously measured via both methods in each participant. Measurements were compared using Bland-Altman analysis.

Results: In total, 29 participants completed the study and provided 144 distinct pairs of pressure measurements that were analyzed. A positive correlation between the two methods was found (R2 = 0.93). There was good agreement between the methods, with a mean bias (95% CI) of -0.4 (-0.6, -0.1) mmHg and a standard deviation of 1.3 mmHg, which was statistically significant but of no clinical importance. The limits of agreement (where 95% of the differences are expected to fall) were -2.9 and 2.2 mmHg. The proportional error was statistically insignificant (p = 0.85), suggesting a constant agreement between the methods across the range of values tested. The percentage error was 10.7%.

Conclusions: Continuous IAP measurements using the novel monitor performed well in the clinical setup of controlled intra-abdominal hypertension across the evaluated range of pressures. Further studies should expand the range to more pathological values.

Keywords: abdominal compartment syndrome; foley manometer; intra-abdominal hypertension; intra-abdominal pressure monitoring.

Grants and funding

This investigator-initiated study was supported by Sereno Medical Ltd., which provided the monitor system and financial support. The sponsor was not involved in data analysis, interpretation, writing the manuscript, or the decision to publish.