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

November 11, 2022 updated by: Andrej Šribar, University Hospital Dubrava
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 1000
        • University Hospital Dubrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AcumenIQ - HPI guided hemodynamic optimization
HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors)
Diagnostic test: "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.
Active Comparator: 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
Diagnostic test: "Flotrac" guided hemodynamic optimization
Therapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards "Flotrac" sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time weighted average of area under hypotensive threshold
Time Frame: During surgery
During surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative duration of hypotension
Time Frame: During surgery
During surgery
Number of hypotensive events
Time Frame: During surgery
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Dubrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/1807-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Will share anonymized data after article publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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