Hypotension Prediction Index (HPI) in Patients Undergoing Robotic Assisted Radical Prostatectomy

University of Foggia80 enrolled

Overview

Robot assisted radical prostatectomy (RARP) is the leader in robotic treatment for prostate cancer. Goal-directed therapy (GDT) is the approach used, but HPI, a machine learning algorithm analysing arterial waveforms, might offer additional benefits. The aim of this prospective randomised study is to evaluate the cumulative amount of intraoperative arterial hypotension episodes in patients undergoing RARP managed by GDT protocol guided or not by HPI algorithm

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Hypotension During Surgery

Interventions

Hypotension Prediction IndexDEVICE

Fluid management guided by Hypotension Prediction Index

No Hypotension Prediction IndexDEVICE

Fluid management not guided by Hypotension Prediction Index

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * all consecutive patients undergoing RARP; American Society of Anaesthesiology (ASA) SCORE I-III Exclusion Criteria: * Body Mass Index (BMI) of 18.5 to 35, uncontrolled arrhythmias, myocardial infarction or ischemic/hemorrhagic stroke in the last 6 months, III/IV stage Global Initiative for Chronic Obstructive Lung Disease, pulmonary fibrosis, contraindication to radial artery cannulation.

Locations (1)

Ospedali Riuniti

Foggia, Apulia, Italy

Outcomes

Primary Outcomes

cumulative amount of time spent in Hypotension

the cumulative amount of intraoperative hypotension, measured by Time Weighted Average (TWA) of Mean Arterial Pressure (MAP) below 65 mmHg

Time frame: intraoperative

Data from ClinicalTrials.gov

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