Mohamed Y Okasha1, Joao Resends-Neto2, Abdallah El-Falou1, Youssef Helwa1, Kenan Habib1, Ricky Tjandra1, Mohamad Soltani3. 1NERv Technology Inc., 2St. Michael’s Hospital, 3University of Waterloo
Introduction: Anastomotic Leaks are one of the most dreaded post-operative complications with a 10-15% mortality rate in approximately 130,000 annual high-risk abdominal surgeries in North America alone. The longer it takes to detect said leaks, the higher the mortality rate. The current standard of care relies heavily on imaging and medical checkups which can be unreliable and may take a long time to reach a diagnosis. Hence, early detection is essential to mitigate leaks before further complications. We have developed and tested a novel medical device platform (NERv Technology Inc. Waterloo, ON, Canada) that can wirelessly monitor real-time pH and conductivity changes in surgical drainage catheters postoperatively for early detection of anastomotic leaks. The device is designed to integrate inline onto surgical drains between the tubing and the bulb/reservoir. The device platform comprises µ-sized (500×500μm) sensors embedded in an 11.6mm channel in addition to an electronic system that captures and records information from the sensors, with the ability to wirelessly transmit data.
Methods: A swine model was used to test the device platform. A laparotomy was performed, and two Jackson-Pratt (JP) drains were placed inside the peritoneum. A small 5cm incision was made to the antrum, and was stitched closed with suture with the distal end of the suture placed outside the body. The animal was closed and one drain was clipped shut. The small 64×45.4mm device designed to integrate inline onto surgical drains between the tubing catheter and the bulb/reservoir was attached to the second drain. The device was left to continuously monitor pH, conductivity and temperature data from the surgical drain fluid in real-time. Two leak incidents were induced. The first incident was induced by injecting gastric fluid through the clipped drain, and the second incident was induced by pulling the distal end of the suture which is stitching the antrum from outside the body.
Results: The device was effectively able to measure and record real-time pH, conductivity and temperature of peritoneal fluid in the JP drain. The pH and conductivity response could be used to diagnose the leak early. The pH of the drainage fluid significantly dropped and conductivity of the solution rose for both events. Chemical changes were observed within minutes after individual leaks were induced. Once admixture of peritoneal and gastric fluid reached the device, chemical changes could be immediately observed.
Conclusion: The novel device has the ability to diagnose gastric leaks early. It also possesses the ability to wirelessly transmit data to enable remote monitoring. The device should be able to detect intraperitoneal leaks caused by different luminal fluids where the device’s sensors were previously individually tested; however, this study was the first to utilize the entire sensors and communications platform. The device’s objective is to decrease anastomotic leak morbidity and mortality by enabling early diagnosis and earlier intervention.
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This abstract was accepted for Poster presentation at the 2020 SAGES Virtual Meeting in the topic. Its program number was: ETP599 and its Abstract ID was: 106245