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

NCT05341167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-03-19

No results posted yet for this 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.

Conditions

  • Intraoperative Hypotension

Interventions

DEVICE

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

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

DRUG

Vasoactive Agent

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.

Sponsors & Collaborators

  • Attikon Hospital

    lead OTHER

Principal Investigators

  • Paraskevi Matsota, Prof · 2nd Department of Anesthesiology, Attikon University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2023-11-04
Completion
2024-10-10

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05341167 on ClinicalTrials.gov