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

N/ANot Yet RecruitingNCT07840937

Autonomous Healthcare, Inc.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Intraoperative Hypotension

Interventions

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.