An interventional study of E-Fusion Vasopressor Titration-Assist in Intraoperative Hypotension, sponsored by Autonomous Healthcare, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Autonomous Healthcare, Inc. · Not applicable, Interventional, and Device feasibility
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.
Exclusion Criteria:
All subjects receive standard anesthetic care. E-Fusion displays advisory norepinephrine infusion rate recommendations that the anesthesia provider may accept or ignore.
Device: E-Fusion Vasopressor Titration-Assist
Clinical 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.
Time frame: Intraoperative period, from E-Fusion activation to deactivation or end of surgery, up to 8 hours
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 frame: Intraoperative period, up to 8 hours
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.
Time frame: Intraoperative period, up to 8 hours
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Autonomous Healthcare, Inc.