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

University of Foggia

Status: Completed

Conditions: Hypotension During Surgery

Treatments: Device: No Hypotension Prediction Index; Device: Hypotension Prediction Index

Study type: Interventional

Funder types: Other

Identifiers

NCT06535464

135/C.E. 2021

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Goal-directed therapy guided by Hypotension Prediction Index algorithm

Active Comparator group

Treatment:

Device: Hypotension Prediction Index

Goal-directed therapy alone

Sham Comparator group

Treatment:

Device: No Hypotension Prediction Index