Closed-Loop Titration of Vasopressor Infusions: Feasibility Study or Proof of Concept Study
Condition: Closed-Loop Communication; Hemodynamic Instability
Study type: Interventional

Summary: 
      The purpose of this 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 or Clearsight system, Edwards
      Lifesciences, IRVINE, USA).
    

Detailed description: 
      In this protocol, the investigators will report the percentage of case time in hypotension
      (defined as Mean arterial pressure (MAP) < 65mmHg). The target MAP will be set at 70mmHg,
      except for neuro embolisation case where MAP can be higher. The investigators want to
      demonstrate that the closed-loop system can prevent hypotension at this specific set point.

      The Investigators have shown this to be the case in simulation studies and in-vivo animal
      studies (under submission) but not yet experimentally in a clinical setting. Investigators
      will recruit their patients from the surgical record that that require a mini-invasive or a
      non-invasive cardiac output monitoring (EV1000 monitoring using the Flotrac or clearsight
      system) ; either high risk patients undergoing high risk surgery (vascular-cardiac- Major
      Abdominal or renal transplant, neuro-endo-vascular surgery (aneuvrysm) and require mechanical
      ventilation and consent to participate in the study will be included in the study.

      The investigators will also test the system in a short series of patients in the ICU setting
      ( critically ill patients): ideally in 3-4 "types" of patients ( septic patients, neuro ICU
      patients, ARDS patients and postoperative patients( ideally intubated patients or sedated
      patients) .The target mean arterial pressure can be different from the 70 mmHg of the
      surgical patients especially for the neurologic patients (head trauma injury patients or
      neuro-endovascular surgical patients). In these two subgroups of patients, the target MAP can
      even vary during the case depending on the surgeons requests (neuro radiologists) or
      depending on cerebral autoregulation.

      Participants will receive standard patient care in that in no way will their anesthetic or
      surgical procedure will be altered as part of the study, with the exception of vasopressor
      administration. Fluids will be given as goal directed therapy using the assisted fluid
      management software present in the EV1000 monitor (only for vascular and abdominal cases).

      The closed loop (automated) system will use an infusion pump (Q-Core) and a controller (a
      computer run index and algorithm developed by Sironis) to make frequent, regular and accurate
      adjustments to the amount of vasopressor infusion rate the patient receives using feedback
      from standard operating room monitors at ERASME HOSPITAL Data from this study will also be
      retrospectively compared to subjects case matched to evaluate differences in MAP time in
      target, total amount of vasopressor received, and patient outcomes (for patients undergoing
      high risk surgery and/or neuro endovascular patients)
    

Intervention name(s): closed-loop
Intervention type(s): Device
Intervention description(s): Vasopressor admnistration in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of vasopressor the patient receives using feedback from standard operating room monitors.
Intervention model: Single Group Assignment
Intervention model description: SINGLE GROUP ASSIGNMENT
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: closedloop; vasopressor