Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery

Study Overview
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Brief Summary
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Intraoperative hypotension is linked to increased incidence of perioperative adverse events such as myocardial and cerebrovascular infarction and acute kidney injury. Hypotension prediction index (HPI) is a novel machine learning guided algorithm which can predict hypotensive events using high fidelity analysis of pulse-wave contour. Goal of this trial is to determine whether use of HPI can reduce the number and duration of hypotensive events in patients undergoing major thoracic procedures.

Official Title
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Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery

Conditions
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Hypotension During Surgery

Intervention / Treatment
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* Diagnostic Test: Acumen IQ guided hemodynamic optimization
* Diagnostic Test: Flotrac guided hemodynamic optimization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 18 years of age patients scheduled for elective major thoracic procedure (lung resection, pleurectomy or resection of the esophagus) planned thoracotomy and intraoperative period of one lung ventilation planned postoperative admission to the ICU Exclusion criteria: persistent atrial fibrillation structural heart defects (shunting or moderate to severe valvular anomalies) preoperative serum hemoglobin levels < 120 g/L severe heart failure classified as New York Heart Association (NYHA) grade IV

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcumenIQ - HPI guided hemodynamic optimization<br>HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors) | Diagnostic Test: Acumen IQ guided hemodynamic optimization<br>* Hypotension prediction index (HPI) available with the Edwards Acumen IQ sensor will be used as an early warning system and a diagnostic screen will be used to guide therapeutic interventions.<br>|
| Active Comparator: Flotrac - conventional GDT guided hemodynamic optimization<br>GDT guided hemodynamic optimization - MAP > 65 mmHg, CI ≥ 2.4 l/min/m2, SVI ≥ 30 ml/beat/m2 and SVRI 1700-2400 dyn·s·cm-5/m2 | Diagnostic Test: Flotrac guided hemodynamic optimization<br>* Therapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards Flotrac sensor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time weighted average of area under hypotensive threshold |  | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative duration of hypotension |  | During surgery | 
| Number of hypotensive events |  | During surgery |