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Hemodynamic Optimization Using an Artificial Intelligenze System (SIMPLY)

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Fluid Management
Hemodynamic (MAP) Stability

Treatments

Device: assisted fluid therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07366164
7755 (Other Identifier)

Details and patient eligibility

About

This study will investigate the impact of using an automated fluid management system on intraoperative fluid therapy in patients undergoing colorectal surgery. The aim is to evaluate whether automated guidance can optimize hemodynamic stability and reduce the incidence of arterial hypotension,

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

- patients >18 years old and ASA 3 scheduled for laparoscopic colorectal surgery

Exclusion criteria

  • Refusal of consent
  • Body Mass Index > 35 kg/m2
  • urgent cases
  • pregnancy

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

treatment group
Experimental group
Description:
fluid therpay fo this grioup will be giuded through the assisted fluid management system
Treatment:
Device: assisted fluid therapy
control group
No Intervention group
Description:
patients belonging to this group will receive fluids following a standard hemodynamic protocol

Trial contacts and locations

1

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Central trial contact

Paola Aceto, professor; andrea russo, medical doctor

Data sourced from clinicaltrials.gov

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