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Completed

NCT Number: NCT05341167

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Athens "Georgios Gennimatas", Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

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

Device

The HPI algorithm will be used in order to prevent hypotensive episodes. When the HPI is greater than 85%, the anesthesiologist will have to intervene within the next 2 minutes taking the hemodynamic parameters available into consideration, as well as the treatment protocol that has been designed according to current literature

Other names: noradrenaline, phenylephrine

Vasoactive Agent

Drug

Hypotensive episodes will be treated with vasoactive agents and fluids. The HPI algorithm recordings will be blinded and will not be available to the anesthesiologist for the duration of the operation.

Other names: noradrenaline, phenylephrine

Primary outcomes

  1. Time-weighted average (TWA) in hypotension

    Time frame: Up to 15 minutes after the end of operation

    Time-weighted average (TWA) in hypotension will be calculated in all patients.

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

Use of the Hypotension Prediction Index Algorithm (HPI) for the Prevention of Intraoperative Hypotension (IOH) in Adult Patients Undergoing Spinal Surgery: Study Protocol for a Randomized Clinical Trial

Acronym: HPIFPIOH

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2022
Registry last updated
Mar 19, 2025

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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