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

NCT07840937 | Not Yet Recruiting FDA Device

• 2 other identifiers: EF-SPINE-0011R43HL187059-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

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

  Intraoperative period, up to 8 hours

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

  Intraoperative period, up to 8 hours

Study Arms (1)

E-Fusion clinical decision support

EXPERIMENTAL

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

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.

E-Fusion clinical decision support

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Autonomous Healthcare, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Ashish Khanna, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Behnood Gholami, PhD

  Autonomous Healthcare, Inc.

  STUDY DIRECTOR

Central Study Contacts

Behnood Gholami, PhD

CONTACT

347-774-1617; info@autonomoushealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)