Closed-Loop Communication Clinical Trial
Official title:
Evaluation of Closed-loop Control of Vasopressor Infusion in Critically Ill Patients: A Pilot Study
The purpose of this pilot study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.
The investigators have developed an automated closed-loop system for vasopressor
administration . They will test it in critically ill patients. The investigators want to
demonstrate that the closed-loop system can maintain mean arterial pressure ( MAP) within a
very narrow range (within +/- 5 mmHg of the predefined MAP target) for more than 85 % of the
treatment time.
The Investigators have shown this to be the case in simulation studies and in-vivo animal
studies and in surgical patients but not yet in the Intensive care unit (ICU). Investigators
will recruit 10 to 12 ICU patients equipped with a mini-invasive cardiac output monitoring
and under continuous norepinephrine infusion.
These patients will typically include: septic patients, neuro ICU patients, ARDS patients,
trauma patients or postoperative patients.
The target MAP will be determined by the ICU physician in charge of the patient.
Fluids will be given standard of care. The closed loop (automated) system will use an
infusion pump (Q-Core and chemyx pump) and a controller (a computer run index and algorithm
developed by Sironis) to make frequent, regular and accurate adjustments of vasopressor
(norepinephrine)
The goal is to register a period of two hours of closed-loop control of MAP.
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