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Bench Validation of a Handcrafted Prototype Catheter for Intra-gastric Pressure Monitoring
Alberto Federico García1,2,3, Julián Chica Yantén4,5, Álvaro Ignacio Sánchez4,6
1Center for Clinical Research (CIC), Fundación Valle del Lili, Carrera 98 No. 18-49, Torre 7, Piso 3 (CIC), Cali, Colombia. alberto.garcia@fvl.org.co.
Background:
Abdominal compartment syndrome is a sustained intra-abdominal pressure (IAP) >20 mm Hg associated with new organ dysfunction. In order to prevent its development and related complications, IAP monitoring should be performed in patients with risk factors. Although techniques for its monitoring have been developed, they are of high cost and not always available in low- and lower-middle-income countries. Therefore, we aim to develop and validate in a bench model a handcrafted catheter to be used as an alternative method to measure the intra-gastric pressure (IGP) as a surrogate of the IAP.
Methods:
We used an acrylic water container as a model of the abdomen and four handcrafted catheters made of a 16 Fr Levin tube with a globe finger tied with silk in the distal end, inflated with 1 cm of air. They were placed on the bottom of the container where the water pressure was directly measured as a gold standard. The agreement between the two measures was assessed with the Bland-Altman method.
Results:
We performed 120 simultaneous measures. The mean pressure difference was 0.218 (95% CI 0.074 to 0.363).
Conclusions:
The handcrafted prototype catheter and the direct measure were highly correlated. The new catheter is a reliable and reproducible tool for pressure monitoring. However, before it can be used in the clinical setting for IAP monitoring, validation in human models in a real clinical setting needs to be performed.
