Hypotension Prediction Index (HPI) in Patients Undergoing Robotic Assisted Radical Prostatectomy
Not Applicable
Completed
- Conditions
- Hypotension During Surgery
- Interventions
- Device: No Hypotension Prediction IndexDevice: Hypotension Prediction Index
- Registration Number
- NCT06535464
- Lead Sponsor
- University of Foggia
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Goal-directed therapy alone No Hypotension Prediction Index - Goal-directed therapy guided by Hypotension Prediction Index algorithm Hypotension Prediction Index -
- Primary Outcome Measures
Name Time Method cumulative amount of time spent in Hypotension intraoperative the cumulative amount of intraoperative hypotension, measured by Time Weighted Average (TWA) of Mean Arterial Pressure (MAP) below 65 mmHg
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ospedali Riuniti
🇮🇹Foggia, Puglia, Italy