A study to assess the safety and efficacy of Navigator in post operative cardiac surgery patients versus conventional care.

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Post surgical patients often display instability in their blood pressure and flow (haemodynamic circulation) which, if not stabilized, can lead to a range of side effects such as reduced urine output, kidney failure, fluid in the lungs, disorganized and ineffective pumping of the blood by the heart, and stroke. These side effects usually require an extended hospital stay, additional investigations and medications, and all lead to additional cost. Navigator software has been developed to link with the patient’s bedside monitor and acquire and process data collected by the monitor. This data is then displayed graphically relative to target ranges for a variety of heart measurements that were determined by the physician specifically for the patient and entered into Navigator at the start of monitoring. This provides the physician with a real time picture of the patient’s blood pressure and flow, in comparison to the prescribed values he would like to achieve and provides unique guidance as to what fluid and medication treatments could be administered to make the patient more stable. The aim of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by Navigator provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target blood pressure and flow stability in the post operative patient when compared to conventional care in an ICU setting. The study will be conducted in 100 post-cardiac surgery patients male and female aged 18 and over that have undergone coronary bypass grafting and/or heart valve repair or replacement whilst utilizing heart lung perfusion pump (50 patients per study group). Patients that meet all of the inclusion / exclusion criteria will have a 50:50 chance of being randomized to one of two study groups, Navigator or control (conventional care). All patients will be connected to a bedside monitor which in turn is connected to an Avantech computer with the Navigator software installed. Those patients randomized to the Navigator group will have the full Navigator functions available; for those patients randomized to the control group the physician will still determine target values for the heart measurements, however once control is selected on the Navigator screen the graphical part of the screen will go blank. Each patient will be connected to Navigator for as long as their doctor wishes to have their heart function closely monitored by their heart catheter. Once this catheter is removed, Navigator will be disconnected. This will be between the day after surgery and around a week after surgery, depending on the speed of recovery. All patients will undergo standard treatments during their hospital stay. The aim of this study therefore, is to demonstrate that real time aquisition and subsequent processing and display of data produced by Navigator provides the clinican with the appropriate data and guidance to acheive and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an ICU setting. Acheiving early haemodynamic stability in the post operative cardiac patient as it is hoped will lead to improved patient outcome and reduced associated costs.

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