This is a single-arm feasibility study of E-Fusion Vasopressor Titration-Assist, a clinical decision support software, in 10 adults undergoing multi-level spine surgery. E-Fusion monitors blood pressure from the patient monitor and displays recommended changes to the norepinephrine infusion rate. The anesthesia provider independently reviews each recommendation and may accept or ignore it. The software does not connect to or control the infusion pump. The primary objective is to assess safety by evaluating adverse events attributable to E-Fusion during surgery. Secondary objectives evaluate clinician agreement with the recommendations and blood pressure management.
Age 22 years or older
Patient or a legally authorized representative (LAR) has provided written informed consent
Patient is expected to receive norepinephrine through a central line, PICC line, or peripheral line for blood pressure management
Patient's blood pressure is monitored with an arterial line
Confirmed pregnancy and/or nursing mothers
Currently participating in another interventional study
Patients who are likely to bleed excessively and/or need rapid transfusion
Patients expected to be disconnected and transported for imaging during the study procedure
Single group
E-Fusion Vasopressor Titration-Assist
DeviceClinical decision support software that monitors mean arterial pressure from the patient monitor and displays recommended norepinephrine infusion rate changes. The clinician independently evaluates each recommendation and makes all infusion rate changes manually. The software does not connect to or control the infusion pump.
Number of adverse events and serious adverse events of relevance attributed to E-Fusion
Number of adverse events (AEs) and serious adverse events (SAEs) of relevance occurring during surgery, attributed to E-Fusion based on clinician assessment, including major adverse cardiac events, intraoperative arrhythmia, and infusion-related injury.
Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider
Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider after their independent review.
Time-weighted average mean arterial pressure (TWA-MAP) above and below target
Time-weighted average MAP above and below the clinician-set target, stratified by compliance group: high (greater than 80%), medium (50-80%), and low (less than 50%) compliance with E-Fusion recommendations.
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Autonomous Healthcare, Inc.
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
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