Intraoperative HypotensionHPIFPIOHNCT05341167
HPI Algorithm for the Prevention of IOH During Spinal Surgery [HPIFPIOH]
A study testing HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi and Vasoactive Agent in people with Intraoperative Hypotension, run by Attikon Hospital at 2 sites in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi and Vasoactive Agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesGreece
- Study dates
- 11 May 2022to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
General Hospital of Athens "Georgios Gennimatas"
Athens, Attica, 11527
Attikon Hospital
Athens
About this study
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
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.
Read the 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.
- Conditions
- Intraoperative Hypotension
- Being tested
- HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi, Vasoactive Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpiDevice
Also called noradrenaline, phenylephrine
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 AgentDrug
Also called noradrenaline, phenylephrine
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: | Active comparator | 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 Receives: Device: HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi; Drug: Vasoactive Agent |
| Control group: | Other | 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. Receives: Drug: Vasoactive Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted average (TWA) in hypotension
Time-weighted average (TWA) in hypotension will be calculated in all patients.
Measured: Up to 15 minutes after the end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start11 May 2022
- Primary completion4 Nov 2023
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Double-Blinded clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paraskevi Matsota, Attikon Hospital
- Investigators
- Paraskevi Matsota, Prof, Principal investigator, 2nd Department of Anesthesiology, Attikon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341167
- Sponsor's protocol ID
- HPIFPIOH
- Acronym
- HPIFPIOH
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40410627
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05341167
- Acronym / sponsor ID
- HPIFPIOH / HPIFPIOH
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Double-Blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group: | Active comparator | Device: HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi, Drug: Vasoactive AgentThe 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 |
| Control group: | Other | Drug: Vasoactive AgentHypotensive 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpiAlso: noradrenaline, phenylephrineThe 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 | Intervention group: |
| Vasoactive AgentAlso: noradrenaline, phenylephrineHypotensive 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. | Drug | Control group:, Intervention group: |
Primary outcome
Time-weighted average (TWA) in hypotension
Time frame: Up to 15 minutes after the end of operation
Time-weighted average (TWA) in hypotension will be calculated in all patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 40410627Pilakouta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paraskevi Matsota, Prof principal investigator
2nd Department of Anesthesiology, Attikon University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPI algorithm using Edwards device https://www.edwards.com/gb/devices/decision-software/hpi and Vasoactive Agent in people with Intraoperative Hypotension, run by Attikon Hospital at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted average (TWA) in hypotension (time frame: Up to 15 minutes after the end of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.