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

Not Applicable

Completed

• Conditions: Hypotension During Surgery
• Interventions: Diagnostic Test: "Flotrac" guided hemodynamic optimization; Diagnostic Test: "Acumen IQ" guided hemodynamic optimization

• Registration Number: NCT05615168
• Lead Sponsor: University Hospital Dubrava

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-30
• Study First Submitted: 2022-10-26
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-11
• Last Update Submitted: 2022-11-11
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flotrac - conventional GDT guided hemodynamic optimization	"Flotrac" guided hemodynamic optimization	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
AcumenIQ - HPI guided hemodynamic optimization	"Acumen IQ" guided hemodynamic optimization	HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors)

Primary Outcome Measures

Name	Time	Method
Time weighted average of area under hypotensive threshold	During surgery

Secondary Outcome Measures

Name	Time	Method
Number of hypotensive events	During surgery
Cumulative duration of hypotension	During surgery

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Grad Zagreb, Croatia