Hypotension During Surgery
Conditions
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
Interventions
Fluid management guided by Hypotension Prediction Index
DEVICENo Hypotension Prediction Index
Fluid management not guided by Hypotension Prediction Index
Sponsors
University of Foggia
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed