NCT05341167

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

May 11, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

April 17, 2022

Last Update Submit

March 15, 2025

Conditions

Intraoperative Hypotension

Outcome Measures

Primary Outcomes (1)

  • Time-weighted average (TWA) in hypotension

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

    Up to 15 minutes after the end of operation

Study Arms (2)

Intervention group:

ACTIVE COMPARATOR

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

Device: HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpiDrug: Vasoactive Agent

Control group:

OTHER

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

Drug: Vasoactive Agent

Interventions

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

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

Also known as: noradrenaline, phenylephrine
Intervention group:
Vasoactive AgentDRUG

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.

Also known as: noradrenaline, phenylephrine
Control group:Intervention group:

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Hospital of Athens "Georgios Gennimatas"

Athens, Attica, 11527, Greece

Location

Attikon Hospital

Athens, Greece

Location

Related Publications (1)

  • Pilakouta Depaskouale MA, Archonta SA, Moutafidou SKappa, Paidakakos NA, Dimakopoulou AN, Matsota PK. Effectiveness of hypotension prediction index software in reducing intraoperative hypotension in prolonged prone-position spine surgery: a single-center clinical trial. J Clin Monit Comput. 2025 Oct;39(5):875-887. doi: 10.1007/s10877-025-01303-0. Epub 2025 May 23.

    PMID: 40410627DERIVED

MeSH Terms

Interventions

Vasoconstrictor AgentsNorepinephrinePhenylephrine

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Paraskevi Matsota, Prof

    2nd Department of Anesthesiology, Attikon University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Not aware of the study group
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective, Randomized, Double-Blinded clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof of Anestehsiology

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

May 11, 2022

Primary Completion

November 4, 2023

Study Completion

October 10, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(2)