Preclinical and clinical validation of a novel oxygenation imaging system

Introduction: Two major disadvantages of currently available oxygenation probes are the need for contact with the skin and long measurement stabilization times. A novel oxygenation imaging device based on spatial frequency domain and spectral principles has been designed, validated preclinically on pigs, and validated clinically on humans. Importantly, this imaging system has been designed to operate under the rigorous conditions of an operating room. Materials and Methods: Optical properties reconstruction and wavelength selection have been optimized to allow fast and reliable oxyhemoglobin and deoxyhemoglobin imaging under realistic conditions. In vivo preclinical validation against commercially available contact oxygenation probes was performed on pigs undergoing arterial and venous occlusions. Finally, the device was used clinically to image skin flap oxygenation during a pilot study on women undergoing breast reconstruction after mastectomy. Results: A novel illumination head containing a spatial light modulator (SLM) and a novel fiber-coupled high power light source were constructed. Preclinical experiments showed similar values between local probes and the oxygenation imaging system, with measurement times of the new system being < 500 msec. During pilot clinical studies, the imaging system was able to provide near real-time oxyHb, deoxyHb, and saturation measurements over large fields of view (> 300 cm2). Conclusion: A novel optical-based oxygenation imaging system has the potential to replace contact probes during human surgery and to provide quantitative, wide-field measurements in near real-time.