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A circulatory guidance system, Navigator™, was evaluated in a prospective, randomised control trial at six Australian university teaching hospitals involving 112 scheduled postoperative cardiac surgical patients with pulmonary artery catheters placed and receiving 1:1 nursing care. The guidance system was used to achieve and maintain physician-designated cardiac output and mean arterial pressure targets and compared these with standard post open-heart surgery care. The primary efficacy endpoint was the standardised unsigned error between the targeted and the actual values for cardiac output and mean arterial pressure, time averaged over the duration of cardiac output monitoring – the average standardised distance. This was 1.71 (SD=0.65) for the guidance group and 1.92 (SD=0.65) in the control group (P=0.202). Rates of postoperative atrial fibrillation, adverse events, intensive care unit and hospital length-of-stay were similar in both groups. There were no device-related adverse events. Guided haemodynamic therapy with the Navigator™ device was non-inferior to standard intensive care unit therapy. The study was registered with ClinicalTrials.gov Identifier NCT00468247.

Computer Based Haemodynamic Guidance System is Effective and Safe in Management of Postoperative Cardiac Surgery Patients