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

NCT ID: NCT05615168

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-08-30

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.

Detailed Description

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Conditions

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Hypotension During Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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AcumenIQ - HPI guided hemodynamic optimization

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

Group Type EXPERIMENTAL

"Acumen IQ" guided hemodynamic optimization

Intervention Type 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.

Flotrac - conventional GDT 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

Group Type ACTIVE_COMPARATOR

"Flotrac" guided hemodynamic optimization

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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"Acumen IQ" guided hemodynamic optimization

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.

Intervention Type DIAGNOSTIC_TEST

"Flotrac" guided hemodynamic optimization

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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Andrej Šribar

Prinicipal investigator, Head of division of cardiovascular anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Dubrava

Zagreb, City of Zagreb, Croatia

Site Status

Countries

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Croatia

Other Identifiers

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2022/1807-03

Identifier Type: -

Identifier Source: org_study_id

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