HPI Algorithm for the Prevention of IOH During Spinal Surgery [HPIFPIOH]

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the hypothesis that the use of the Hypotension Prediction Index algorithm (HPI) can reduce intraoperative hypotension (IOH) in adult patients undergoing spinal surgery in the prone position under general anesthesia, as well as to explore its effect on in-hospital postoperative morbidity and mortality.

Detailed Description
-----------------
The study is a Prospective Randomized clinical trial. Adult patients (>18y) undergoing spinal surgery in the prone position under general anesthesia will be included. The patients will be randomized using a computer-generated, permuted block randomization with a 1:1 allocation into two groups. Intervention group: in this group, the HPI algorithm will be used in order to prevent hypotensive episodes Control group: in this group standard anesthetic care will be provided. Hypotensive episodes will be treated with vasoactive agents and fluids. All patients will receive the same type of anaesthesia (TIVA with propofol) and monitoring including Patient State Index (PSI), non-invasive monitoring of blood pressure, SpO2, continuous electrocardiographic monitoring, ETCO2 and urinary output. Additionally, invasive continuous measurement of the patient's blood pressure will be available via radial artery catheterization. The arterial catheter will be connected to both the standard monitor and the platform which includes the HPI software. Arterial blood gas testing will be performed on an hourly basis. Intraoperative recordings include PSI values, hemodynamic parameters every 10-15 minutes and urinary output every hour. Hemodynamic parameters will also be collected electronically from the monitor. The total doses of propofol, opioids/sedatives, fluids and vasoactive agents will also be recorded, as well as the estimated blood loss. In this study, time-weighted average (TWA) in hypotension will be calculated in all patients.[TWA= depth of hypotension x time spent in hypotension / total surgery time]. Postoperatively Blood sampling for hs-TropI will be collected after the surgical procedure and during the following 3 postoperative days. If an increase in the levels hs-Trop I is noted the patient will be inquired for symptoms of myocardial ischemia and a new ECG will be performed. A cardiology consultation will be requested, if necessary. Creatinine levels and urinary output will be monitored during the first 2 postoperative days. Acute kidney injury will be assessed according to the AKIN classification. All in-hospital incidents and in-hospital mortality will also be documented.

Official Title
-----------------
Use of the Hypotension Prediction Index Algorithm (HPI) for the Prevention of Intraoperative Hypotension (IOH) in Adult Patients Undergoing Spinal Surgery: Study Protocol for a Randomized Clinical Trial

Conditions
-----------------
Intraoperative Hypotension

Intervention / Treatment
-----------------
* Device: HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi
* Drug: Vasoactive Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia Exclusion Criteria: Heart failure with reduced ejection fraction (LVEF<35%) Severe aortic and/or mitral regurgitation Persistent atrial fibrillation or other significant cardiac arrhythmias Significant preoperative hypotension End-stage renal disease on dialysis/RRT

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized, Double-Blinded clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group:<br>The HPI algorithm will be used in order to prevent hypotensive episodes. When the HPI is greater than 85%, the anesthesiologist will have to intervene within the next 2 minutes taking the hemodynamic parameters available into consideration, as well as the treatment protocol that has been designed according to current literature | Device: HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi<br>* The HPI algorithm will be used in order to prevent hypotensive episodes. When the HPI is greater than 85%, the anesthesiologist will have to intervene within the next 2 minutes taking the hemodynamic parameters available into consideration, as well as the treatment protocol that has been designed according to current literature<br>* Other names: phenylephrine;Drug: Vasoactive Agent<br>* Hypotensive episodes will be treated with vasoactive agents and fluids. The HPI algorithm recordings will be blinded and will not be available to the anesthesiologist for the duration of the operation.<br>* Other names: phenylephrine;|
| Other: Control group:<br>Hypotensive episodes will be treated with vasoactive agents and fluids according to the standard clinical practice. The HPI algorithm recordings will be blinded and will not be available to the anesthesiologist for the duration of the operation. | Drug: Vasoactive Agent<br>* Hypotensive episodes will be treated with vasoactive agents and fluids. The HPI algorithm recordings will be blinded and will not be available to the anesthesiologist for the duration of the operation.<br>* Other names: phenylephrine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted average (TWA) in hypotension | Time-weighted average (TWA) in hypotension will be calculated in all patients. | Up to 15 minutes after the end of operation |