Advanced Cardiovascular Management in Major Non-cardiac Surgery.

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Intraoperative Hypotension

Treatments: Device: GDT strategy; Device: HPI-driven intraoperative hemodynamic management strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT07134530

AIMS

Details and patient eligibility

About

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.

Enrollment: 534 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

534 participants in 2 patient groups

High-risk adult patients undergoing major non cardiac surgery

Active Comparator group

Description:

Standard GDT strategy

Treatment:

Device: GDT strategy

high-risk adult patients undergoing major non cardiac surgery

Experimental group

Description:

HPI-driven intraoperative hemodynamic management strategy

Treatment:

Device: HPI-driven intraoperative hemodynamic management strategy