Prospective Observational and Interventional Study Designed to Collect Physiological Data During Elective Surgery

The objective of this observational study is to collect sufficient hemodynamic electronic data from adult subjects in the operating room to support Hemodynamic Algorithm development and bench testing.

It is not a clinical validation study of any hemodynamic algorithm software nor will any investigational hemodynamic algorithm be deployed during this trial. Electronic physiological data prospectively collected with research staff timed observations and comments on both the laptop and Case Record Form (CRF) will support the development of the hemodynamic algorithms in the laboratory setting.

The Key Medical Devices to be used in the study are are non-invasive Class II non-significant risk CE marked SpO2 sensors and pulse oximeter monitors. Additionally, the study would involve use of ‘Covidien Data Acquisition System (DAS)’, to record the pulse oximetry (SpO2) raw photoplethysmogram waveform and monitor physiological data.  ‘Covidien Data Acquisition System (DAS)’ is a laptop based investigational data collection system meeting electrical safety testing.

The Design of the study is primarily observational with only minimal intervention being infusion of a 500 cc bolus of a crystalloid to establish the subject hemodynamic response baseline prior to first incision and the connection of the blood pressure transducer to the arterial access site for measurement of invasive blood pressure for all subjects.