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

July 30, 2024 updated by: Cotoia Antonella, University of Foggia
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Puglia
      • Foggia, Puglia, Italy, 71100
        • Ospedali Riuniti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Goal-directed therapy guided by Hypotension Prediction Index algorithm
Device: Hypotension Prediction Index
Fluid management guided by Hypotension Prediction Index
Sham Comparator: Goal-directed therapy alone
Device: No Hypotension Prediction Index
Fluid management not guided by Hypotension Prediction Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Foggia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135/C.E. 2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not allowed in the consent form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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