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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 10 is below the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Autonomous Healthcare, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Start is estimated for Mar 2027; primary completion for Aug 2027, 5 months later.
Of 217 interventional studies with no phase under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Autonomous Healthcare, Inc.