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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Autonomous Healthcare, Inc.
Study ID
NCT07840937
Status
Not Yet Recruiting

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Conditions

  • Intraoperative Hypotension

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Sep 25, 2026
Start date
Mar 31, 2027
Status verified
Sep 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: E-Fusion clinical decision support
    All subjects receive standard anesthetic care. E-Fusion displays advisory norepinephrine infusion rate recommendations that the anesthesia provider may accept or ignore.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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