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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-directed therapy guided by Hypotension Prediction Index algorithm | Active Comparator |
| |
| Goal-directed therapy alone | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypotension Prediction Index | Device | Fluid management guided by Hypotension Prediction Index |
|
| Measure | Description | Time Frame |
|---|---|---|
| cumulative amount of time spent in Hypotension | the cumulative amount of intraoperative hypotension, measured by Time Weighted Average (TWA) of Mean Arterial Pressure (MAP) below 65 mmHg | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti | Foggia | Apulia | 71100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40493027 | Derived | Cotoia A, Discenza A, Rauseo M, Matella M, Caggianelli G, Ciaramelletti R, Mirabella L, Cinnella G. Intraoperative hypotension during robotic-assisted radical prostatectomy: A randomised controlled trial comparing standard goal-directed fluid therapy with hypotension prediction index-guided goal-directed fluid therapy. Eur J Anaesthesiol. 2025 Oct 1;42(10):916-923. doi: 10.1097/EJA.0000000000002211. Epub 2025 Jun 9. |
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It is not allowed in the consent form
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| No Hypotension Prediction Index | Device | Fluid management not guided by Hypotension Prediction Index |
|