Hemodynamic MAP Stability Clinical Trial
Official title:
Closed-loop Control of Vasopressor Administration in High-Risk Patients Undergoing Cardiac Surgery: A Case Series
Intraoperative hypotension and blood pressure variability are associated with postoperative
complications in surgical patients.
The investigators have developed a closed-loop vasopressor (CLV) controller that titrates
norepinephrine to correct hypotension.
After having tested the system in a small cohort series of patients undergoing major
surgeries, the investigators aimed to test the feasibility of the CLV controller in three
high risk patients undergoing cardiac surgery
The investigators have recently developed an automated closed-loop vasopressor (CLV)
controller to better titrate vasopressor (e.g:norepinephrine) to maintain MAP within a narrow
range (±5mmHg of the chosen target).
The investigators published engineering, animal studies and recently described the
feasibility of titration of norepinephrine in 20 patients undergoing major noncardiac
procedures. This initial cohort human study showed the controller was able to keep patients
within ± 5 mmHg of a target pressure for more than 90% of management time. Cardiac surgery
represents unique challenges in MAP management as the manipulation of the heart itself, the
use of cardiopulmonary bypass (CPB) and cardioplegia, and the pre-existing cardiac disease
all increase the difficulty in maintaining a steady MAP throughout the surgical period.
In this case series the investigators describe three cardiac surgical procedures managed with
the CLV system (one coronary artery bypass graft (CABG) procedure done under CPB; one robotic
minimally invasive direct coronary artery bypass (MIDCAB) procedure (through a
mini-thoracotomy), and one off-pump CABG) in order to assess its feasibility, efficiency and
behavior in three high-risk patients before starting a randomized controlled trial.
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