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

University Hospital Dubrava

Status: Completed

Conditions: Hypotension During Surgery

Treatments: Diagnostic Test: "Flotrac" guided hemodynamic optimization; Diagnostic Test: "Acumen IQ" guided hemodynamic optimization

Study type: Interventional

Funder types: Other

Identifiers

NCT05615168

2022/1807-03

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

AcumenIQ - HPI guided hemodynamic optimization

Experimental group

Description:

HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors)

Treatment:

Diagnostic Test: "Acumen IQ" guided hemodynamic optimization

Flotrac - conventional GDT guided hemodynamic optimization

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: "Flotrac" guided hemodynamic optimization