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

NCT05615168 | Completed FDA Device

• 1 other identifier: 2022/1807-03
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension During Surgery

Outcome Measures

Primary Outcomes (1)

• Time weighted average of area under hypotensive threshold

  During surgery

Secondary Outcomes (2)

• Cumulative duration of hypotension

  During surgery

• Number of hypotensive events

  During surgery

Study Arms (2)

AcumenIQ - HPI guided hemodynamic optimization

EXPERIMENTAL

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

Diagnostic Test: "Acumen IQ" guided hemodynamic optimization

Flotrac - conventional GDT guided hemodynamic optimization

ACTIVE COMPARATOR

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

Interventions

"Acumen IQ" guided hemodynamic optimization DIAGNOSTIC_TEST

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.

AcumenIQ - HPI guided hemodynamic optimization

"Flotrac" guided hemodynamic optimization DIAGNOSTIC_TEST

Therapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards "Flotrac" sensor.

Flotrac - conventional GDT guided hemodynamic optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, City of Zagreb, 1000, Croatia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator, Head of division of cardiovascular anesthesiology

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 14, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CR (1)