HPI Algorithm for the Prevention of IOH During Spinal Surgery [HPIFPIOH]

Last updated: March 15, 2025
Sponsor: Attikon Hospital
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Circulation Disorders

Dizzy/fainting Spells

Treatment

Vasoactive Agent

HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi

Clinical Study ID

NCT05341167
HPIFPIOH
  • Ages 18-90
  • All Genders

Study Summary

The aim of this study is to investigate the hypothesis that the use of the Hypotension Prediction Index algorithm (HPI) can reduce intraoperative hypotension (IOH) in adult patients undergoing spinal surgery in the prone position under general anesthesia, as well as to explore its effect on in-hospital postoperative morbidity and mortality.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients undergoing scheduled spine surgery performed in prone position undergeneral anaesthesia

Exclusion

Exclusion Criteria:

  • Heart failure with reduced ejection fraction (LVEF<35%)

  • Severe aortic and/or mitral regurgitation

  • Persistent atrial fibrillation or other significant cardiac arrhythmias

  • Significant preoperative hypotension

  • End-stage renal disease on dialysis/RRT

Study Design

Total Participants: 85
Treatment Group(s): 2
Primary Treatment: Vasoactive Agent
Phase:
Study Start date:
May 11, 2022
Estimated Completion Date:
October 10, 2024

Study Description

The study is a Prospective Randomized clinical trial. Adult patients (>18y) undergoing spinal surgery in the prone position under general anesthesia will be included.

The patients will be randomized using a computer-generated, permuted block randomization with a 1:1 allocation into two groups.

Intervention group: in this group, the HPI algorithm will be used in order to prevent hypotensive episodes Control group: in this group standard anesthetic care will be provided. Hypotensive episodes will be treated with vasoactive agents and fluids.

All patients will receive the same type of anaesthesia (TIVA with propofol) and monitoring including Patient State Index (PSI), non-invasive monitoring of blood pressure, SpO2, continuous electrocardiographic monitoring, ETCO2 and urinary output. Additionally, invasive continuous measurement of the patient's blood pressure will be available via radial artery catheterization. The arterial catheter will be connected to both the standard monitor and the platform which includes the HPI software. Arterial blood gas testing will be performed on an hourly basis.

Intraoperative recordings include PSI values, hemodynamic parameters every 10-15 minutes and urinary output every hour. Hemodynamic parameters will also be collected electronically from the monitor. The total doses of propofol, opioids/sedatives, fluids and vasoactive agents will also be recorded, as well as the estimated blood loss.

In this study, time-weighted average (TWA) in hypotension will be calculated in all patients.[TWA= depth of hypotension x time spent in hypotension / total surgery time].

Postoperatively Blood sampling for hs-TropI will be collected after the surgical procedure and during the following 3 postoperative days. If an increase in the levels hs-Trop I is noted the patient will be inquired for symptoms of myocardial ischemia and a new ECG will be performed. A cardiology consultation will be requested, if necessary.

Creatinine levels and urinary output will be monitored during the first 2 postoperative days. Acute kidney injury will be assessed according to the AKIN classification.

All in-hospital incidents and in-hospital mortality will also be documented.

Connect with a study center

  • General Hospital of Athens "Georgios Gennimatas"

    Athens, Attiki 11527
    Greece

    Site Not Available

  • Attikon Hospital

    Athens,
    Greece

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.