OBJECTIVE: Cerebral oxygenation monitoring via near-infrared spectroscopy (NIRS) during cardiopulmonary bypass (CPB) is increasingly becoming an accepted and valued component of intraoperative monitoring. In recent years, new devices have become available which all make different claims. The purpose of this study is to examine the research on these individual devices to establish the levels of evidence for each and formulate a research path for further evaluation of this technology in cardiac surgery. METHODS: This study is a systematic review of published research on cerebral oximetry. We searched PubMed, CINAHL and Scopus for full-length, peer-reviewed articles containing original data resulting from the study of patient neurologic outcomes based on the use of FDA-approved near-infrared spectroscopy devices. The studies were then grouped and classified based on the device used and the levels of evidence each study provided. RESULTS: Only a very limited number of high-level clinical evidence research papers are currently available, with nearly all of those papers based on the INVOS system. This is likely due to the different lengths of time each device has been on the market and its availability for use in clinical trials. Challenges to testing include the expense of testing various devices, the lack of a globally accepted gold standard for cerebral oxygenation saturation, the limited availability of patient frontal surface area and the gradual adoption of this technology. Despite these limitations, significant results have been identified in relation to patient outcomes. CONCLUSION: At this time, there is limited high-level evidence available for all of the NIRS devices on the market despite significant outcomes found in these studies. Additional prospective randomized studies should be conducted in order to establish the potential role NIRS may play in patient monitoring as well as assessing the efficacy of the multiple devices on the market.
OBJECTIVE: Cerebral oxygenation monitoring via near-infrared spectroscopy (NIRS) during cardiopulmonary bypass (CPB) is increasingly becoming an accepted and valued component of intraoperative monitoring. In recent years, new devices have become available which all make different claims. The purpose of this study is to examine the research on these individual devices to establish the levels of evidence for each and formulate a research path for further evaluation of this technology in cardiac surgery. METHODS: This study is a systematic review of published research on cerebral oximetry. We searched PubMed, CINAHL and Scopus for full-length, peer-reviewed articles containing original data resulting from the study of patient neurologic outcomes based on the use of FDA-approved near-infrared spectroscopy devices. The studies were then grouped and classified based on the device used and the levels of evidence each study provided. RESULTS: Only a very limited number of high-level clinical evidence research papers are currently available, with nearly all of those papers based on the INVOS system. This is likely due to the different lengths of time each device has been on the market and its availability for use in clinical trials. Challenges to testing include the expense of testing various devices, the lack of a globally accepted gold standard for cerebral oxygenation saturation, the limited availability of patient frontal surface area and the gradual adoption of this technology. Despite these limitations, significant results have been identified in relation to patient outcomes. CONCLUSION: At this time, there is limited high-level evidence available for all of the NIRS devices on the market despite significant outcomes found in these studies. Additional prospective randomized studies should be conducted in order to establish the potential role NIRS may play in patient monitoring as well as assessing the efficacy of the multiple devices on the market.
Authors: Nousjka P A Vranken; Patrick W Weerwind; Nadia A Sutedja; Ervin E Ševerdija; Paul J C Barenbrug; Jos G Maessen Journal: J Extra Corpor Technol Date: 2017-09