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Completed

NCT Number: NCT06535464

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

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

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Key information

Conditions

Hypotension During Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedali Riuniti

Foggia, Apulia, 71100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypotension prediction index

Device

Fluid management guided by Hypotension Prediction Index

No Hypotension Prediction Index

Device

Fluid management not guided by Hypotension Prediction Index

Primary outcomes

  1. cumulative amount of time spent in Hypotension

    Time frame: intraoperative

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

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Acronym: HPI in RARP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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