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

Intraoperative Hypotension Clinical Trial

— HPIFPIOH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05341167
• Other study ID #: HPIFPIOH
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: April 2024

Study information

• Verified date: July 2023
• Source: Attikon Hospital
• Contact: Paraskevi Matsota, Prof
• Phone: 6945544563
• Email: matsota[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 morbidity and mortality.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

Device:
• 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

Drug:
• 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.

Locations

Country	Name	City	State
Greece	Attikon Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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