Tissue ischemia is a major cause of wound dehiscence or anastomotic leakage resulting in significant morbidity and mortality and occurs at a rate of 15 to 25%. Although measurement of systemic blood oxygenation status by pulse oximetry on the finger is a mandatory requirement for every single patient while in the hospital, there are no devices or methods available to measure tissue oxygenation following complex surgical resections and reconstructions in the operating room. Increasingly, surgical procedures are performed by minimally invasive techniques, which add complexity to the problem, as surgeons do not have the opportunity to directly touch, feel or visualize the organs. In a collaboration between The City College of New York (CCNY) bioengineering design team and Memorial Sloan-Kettering Cancer Center (MSKCC) surgeons, we have successfully designed, constructed and tested a novel wireless, handheld intraoperative oximetry (WiPOX) device, which provides real-time, accurate, and convenient intraoperative monitoring of the tissue oxygenation ensuring tissue viability thereby improving surgical outcomes, decreasing mortality, patient hospitalization and the associated costs. In this R03 proposal, based on the feedback from the ongoing clinical trial, we will enhance device performance and accuracy through two further innovations: incorporation of onboard pressure sensors to allow reliable tissue contact and enhancement of S/N through wireless integration with a systemic pulse oximeter. A pipeline for preclinical and clinical testing is in place. These innovative modifications are crucial for surgeons to take the next step of this device utility - to modify the surgical procedure based on tissue oxygenation.
With the development of a compact handheld device for real-time wireless monitoring of tissue oxygen-saturation during surgical procedures, we aim to provide a tool to surgeons to objectively and reliably measure tissue viability during surgery rather than have to rely solely on their (subjective) visual inspection. Routine use of such device could help surgeons to reduce complications as the importance of adequate tissue oxygenation for healing and preventing post-operative complications is well documented.