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NCT Number: NCT07840937

Feasibility Study of E-Fusion Vasopressor Titration-Assist During Multi-Level Spine Surgery

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.

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Key information

Conditions

Intraoperative Hypotension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patient is undergoing multi-level spine surgery with an expected duration of at least 2 hours and not exceeding 8 hours

Exclusion criteria

  • 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
  • History of cardiac arrhythmias
  • Patients receiving another actively titrated vasopressor during study (excluding vasopressin)

Treatment and study plan

E-Fusion Vasopressor Titration-Assist

Device

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.

Primary outcomes

  1. Number of adverse events and serious adverse events of relevance attributed to E-Fusion

    Time frame: Intraoperative period, from E-Fusion activation to deactivation or end of surgery, up to 8 hours

    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.

Secondary outcomes

  1. Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider

    Time frame: Intraoperative period, up to 8 hours

    Percentage of E-Fusion suggested dose changes in agreement with the anesthesia provider after their independent review.

  2. Time-weighted average mean arterial pressure (TWA-MAP) above and below target

    Time frame: Intraoperative period, up to 8 hours

    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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Sponsors and collaborators

Lead sponsor

Autonomous Healthcare, Inc.

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Feasibility Study of E-Fusion Vasopressor Titration-Assist as a Clinical Decision Support Tool During Multi-Level Spine Surgery

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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