Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Ma… (NCT00468247) | Clinical Trial Compass
CompletedPhase 2
Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System
Australia112 participantsStarted 2007-03
Plain-language summary
A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided Circulatory Management System versus conventional care in post-operative cardiac surgery patients. The purpose of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by the Navigator guided circulatory management system provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an Intensive Care Unit setting.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female aged 18 years or older
✓. Undergoing elective cardiac surgery where surgery involves the use of a heart-lung perfusion pump
✓. Will have an arterial line and Swan Ganz catheter in situ
✓. Require invasive measurement of Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP)
✓. Are able and willing to provide written informed consent to participate in the study
Exclusion criteria
✕. Women who are lactating or pregnant
✕. Require Extracorporeal Membrane Oxygenation
✕. Present at baseline screening or immediately prior to randomisation in the ICU with atrial fibrillation (irregular supraventricular rhythm, not due to ectopic complexes with an absence of discrete P-waves lasting more than 10 minutes documented and confirmed with an ECG)
✕. Intra-operative surgical treatment for atrial fibrillation
What they're measuring
1
Average distance to central point of the target cardiovascular zone while connected to the device