Pre-Clinical Validation of A Novel Continuous Intra-Abdominal Pressure Measurement Equipment (SERENNO)

oleh: Salar Tayebi, Robert Wise, Ali Pourkazemi, Johan Stiens, Manu L. N. G. Malbrain

Format: Article
Diterbitkan: MDPI AG 2022-07-01

Deskripsi

<b>Introduction:</b> Increased intra-abdominal pressure (IAP) has an important impact on morbidity and mortality in critically ill patients. The SERENNO Sentinel system (Serenno Medical, Yokne’am Illit, Israel) is a novel device that allows automatic and continuous IAP measurements. <b>Aims:</b> Pre-clinical validation in a bench model study comparing the new device with the gold standard method and two other continuous IAP measurement devices. <b>Methods:</b> IAP measurement with the novel SERENNO device (IAP<sub>SER</sub>) was compared with the gold standard IAP<sub>H2O</sub> (water column height) and two other automatic and continuous IAP measurement devices: IAP<sub>CiM</sub> measured via the CiMON device (Pulsion Medical Systems, Munich, Germany) and IAP<sub>SPIE</sub> measured using the Spiegelberg device (Spiegelberg, Hamburg, Germany), which previously received the CE mark for clinical applications. The IAP measurement was performed six times (<i>n</i> = 6) at each pressure value (between 0 and 35 mmHg) with different methods and the height of the water column in a bench-top phantom was used as the reference IAP for further interpretations. In addition to the quadruple comparisons, intra- and inter-observer variability of IAP measurements were also calculated. Correlation studies and Bland and Altman’s analyses were performed in addition to the concordance study. <b>Results:</b> The CiMON and Spiegelberg devices showed a greater dynamic range and standard deviation when recording IAP<sub>CiM</sub> and IAP<sub>SPIE</sub> compared with IAP<sub>SER</sub>. In general, the maximum and minimum values of IAP recorded with each device (at each level of IAP<sub>H2O</sub>) were significantly different from each other. However, the average values were in very good agreement. The highest correlation was observed between IAP<sub>SER</sub> and IAP<sub>H2O</sub>, and IAP<sub>SER</sub> and IAP<sub>SPIE</sub> (R = 0.99, <i>p</i> = 0.001 for both comparisons and intra- and inter-observer measurements). Although the CiMON and SERENNO systems were in very good agreement with each other, a slightly smaller correlation coefficient was found between them (R = 0.95, <i>p</i> = 0.001, and R = 0.96, <i>p</i> = 0.001 for intra- and inter-observer measurements, respectively). When compared to the gold standard (IAP<sub>H2O</sub>), Bland and Altman’s analysis showed a mean difference of +0.44, −0.25, and −0.04 mmHg for the intra-observer measurements and +0.18, −0.75, and −0.58 mmHg for the inter-observer measurements for IAP<sub>SER</sub>, IAP<sub>CiM</sub>, and IAP<sub>SPIE</sub>, respectively. IAP<sub>SER</sub> showed a small positive bias (overestimation), while IAP<sub>CiM</sub> and IAP<sub>SPIE</sub> showed a negative bias (underestimation) when compared to IAP<sub>H2O</sub>. Further statistical analysis showed a concordance coefficient of 100% with an excellent ability of the SERENNO system in tracking IAP<sub>H2O</sub> changes. <b>Conclusions:</b> Pre-clinical validation of a new IAP monitoring device (SERENNO) showed very promising results when compared with the gold standard and other continuous techniques; however, clinical trials should be followed as the next stage of the validation process. Based on the actual research guidelines, the SERENNO system can be used interchangeably with the gold standard.