Advanced Cardiovascular Management in Major Non-cardiac Surgery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2026-04-30

Brief Summary

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This is a single center, randomised and controlled clinical triaI whose aim is to predict and treat in advance, intraoperative hypotension episodes.

In particular, the aim of the study is to compare the clinical impact of two different hemodynamic strategies based on the use of different monitoring platforms: the Edwards EV1000 equipped with FloTrac sensor and HemoSphere platform equipped with Acumen Hypotension Prediction Index software and Acumen IQ pressure sensor.

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Detailed Description

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Conditions

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Intraoperative Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-risk adult patients undergoing major non cardiac surgery

Standard GDT strategy

Group Type ACTIVE_COMPARATOR

GDT strategy

Intervention Type DEVICE

Current clinical hemodynamic care

high-risk adult patients undergoing major non cardiac surgery

HPI-driven intraoperative hemodynamic management strategy

Group Type EXPERIMENTAL

HPI-driven intraoperative hemodynamic management strategy

Intervention Type DEVICE

Hemodynamic management protocol based on information detected by Edwards HemoSphere monitor equipped with the Acumen Hypotension Prediction Index software (HPI)

Interventions

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HPI-driven intraoperative hemodynamic management strategy

Hemodynamic management protocol based on information detected by Edwards HemoSphere monitor equipped with the Acumen Hypotension Prediction Index software (HPI)

Intervention Type DEVICE

GDT strategy

Current clinical hemodynamic care

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Age ≥ 18 years old
* Surgical indication for major NCS needing general anesthesia
* Anaesthesiologic indication for perioperative arterial cannulation and advanced hemodynamic monitoring

Exclusion Criteria

* Informed Refusal as documented by signature (Appendix Informed Consent Form)
* Age ≤ 18 years old
* Severe aortic valvulopathy
* Atrial fibrillation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No