Evaluation of the TraumaGuard Balloon-in-Balloon Catheter Design for Intra-Abdominal Pressure Monitoring: Insights from Pig and Human Cadaver Studies

Salar Tayebi; Tim McKinney; Cynthia McKinney; Dipak Delvadia; Marc-Alan Levine; Edward S Spofford Jr; Luca Malbrain; Johan Stiens; Wojciech Dabrowski; Manu L N G Malbrain

doi:10.3390/s23218806

Evaluation of the TraumaGuard Balloon-in-Balloon Catheter Design for Intra-Abdominal Pressure Monitoring: Insights from Pig and Human Cadaver Studies

Sensors (Basel). 2023 Oct 29;23(21):8806. doi: 10.3390/s23218806.

Authors

Affiliations

¹ Department of Electronics and Informatics, Vrije Universiteit Brussel, 1050 Brussels, Belgium.
² College of Medicine, Drexel University, Philadelphia, PA 19129, USA.
³ SGU School of Medicine, Danbury University Hospital, Danbury, CT 06810, USA.
⁴ Cricket Innovations, Pottstown, PA 19465, USA.
⁵ Faculty of Medicine, Katholieke Universiteit Leuven, 3000 Leuven, Belgium.
⁶ First Department of Anaesthesiology and Intensive Therapy, Medical University of Lublin, 20-954 Lublin, Poland.
⁷ Medical Data Management, Medaman, 2440 Geel, Belgium.
⁸ International Fluid Academy, 3360 Lovenjoel, Belgium.

Abstract

Introduction: Intra-abdominal pressure (IAP) monitoring is crucial for the detection and prevention of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). In the 1970s, air-filled catheters (AFCs) for urodynamic studies were introduced as a solution to overcome the limitations of water-perfused catheters. Recent studies have shown that for correct IAP measurement with traditional AFC, the bladder needs to be primed with 25 mL of saline solution to allow pressure wave transmission to the transducer outside of the body, which limits continuous IAP monitoring. Methods: In this study, a novel triple balloon, air-filled TraumaGuard (TG) catheter system from Sentinel Medical Technologies (Jacksonville, FL, USA) with a unique balloon-in-balloon design was evaluated in a porcine and cadaver model of IAH via laparoscopy (IAP_gold). Results: In total, 27 and 86 paired IAP measurements were performed in two pigs and one human cadaver, respectively. The mean IAP_TG was 20.7 ± 10.7 mmHg compared to IAP_gold of 20.3 ± 10.3 mmHg in the porcine study. In the cadaver investigation, the mean IAP_TG was 15.6 ± 10.8 mmHg compared to IAP_gold of 14.4 ± 10.4 mmHg. The correlation, concordance, bias, precision, limits of agreement, and percentage error were all in accordance with the WSACS (Abdominal Compartment Society) recommendations and guidelines for research. Conclusions: These findings support the use of the TG catheter for continuous IAP monitoring, providing early detection of elevated IAP, thus enabling the potential for prevention of IAH and ACS. Confirmation studies with the TraumaGuard system in critically ill patients are warranted to further validate these findings.

Keywords: abdominal compartment syndrome; air-filled catheter; balloon-in-balloon design; continuous measurement; intra-abdominal hypertension; intra-abdominal pressure; supine position.

MeSH terms

Animals
Catheters
Critical Illness
Humans
Intra-Abdominal Hypertension* / diagnosis
Swine

Grants and funding

This research study was supported by an unrestricted educational and research grant by Sentinel Medical Technologies (Jacksonville, FL, USA) providing the study devices free of charge and covering the open access publication fee.