HPI Algorithm for the Prevention of IOH During Spinal Surgery [HPIFPIOH]
NCT ID: NCT05341167
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
85 participants
INTERVENTIONAL
2022-05-11
2024-10-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intervention group:
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
HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi
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
Vasoactive Agent
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.
Control group:
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.
Vasoactive Agent
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.
Interventions
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HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi
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
Vasoactive Agent
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe aortic and/or mitral regurgitation
* Persistent atrial fibrillation or other significant cardiac arrhythmias
* Significant preoperative hypotension
* End-stage renal disease on dialysis/RRT
18 Years
90 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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Paraskevi Matsota
Prof of Anestehsiology
Principal Investigators
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Paraskevi Matsota, Prof
Role: PRINCIPAL_INVESTIGATOR
2nd Department of Anesthesiology, Attikon University Hospital
Locations
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General Hospital of Athens "Georgios Gennimatas"
Athens, Attica, Greece
Attikon Hospital
Athens, , Greece
Countries
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References
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Pilakouta Depaskouale MA, Archonta SA, Moutafidou SKappa, Paidakakos NA, Dimakopoulou AN, Matsota PK. Effectiveness of hypotension prediction index software in reducing intraoperative hypotension in prolonged prone-position spine surgery: a single-center clinical trial. J Clin Monit Comput. 2025 Oct;39(5):875-887. doi: 10.1007/s10877-025-01303-0. Epub 2025 May 23.
Other Identifiers
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HPIFPIOH
Identifier Type: -
Identifier Source: org_study_id
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