Back to resultsUse of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
Primary Purpose
Hypotension During Surgery
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
"Acumen IQ" guided hemodynamic optimization
"Flotrac" guided hemodynamic optimization
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypotension During Surgery
Eligibility Criteria
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
Sites / Locations
- University Hospital Dubrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AcumenIQ - HPI guided hemodynamic optimization
Flotrac - conventional GDT guided hemodynamic optimization
Arm Description
HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors)
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
Outcomes
Primary Outcome Measures
Time weighted average of area under hypotensive threshold
Secondary Outcome Measures
Cumulative duration of hypotension
Number of hypotensive events
Full Information
NCT ID
NCT05615168
First Posted
October 26, 2022
Last Updated
November 11, 2022
Sponsor
University Hospital Dubrava
1. Study Identification
Unique Protocol Identification Number
NCT05615168
Brief Title
Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
Official Title
Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension During Surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AcumenIQ - HPI guided hemodynamic optimization
Arm Type
Experimental
Arm Description
HPI guided hypotension prediction alarms... Interventions based on SVV (fluid), dp/dt (inotropes), EAdyn (pressors)
Arm Title
Flotrac - conventional GDT guided hemodynamic optimization
Arm Type
Active Comparator
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
"Acumen IQ" guided hemodynamic optimization
Intervention Description
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
Intervention Name(s)
"Flotrac" guided hemodynamic optimization
Intervention Description
Therapeutic interventions guided by real time monitored hemodynamic parameters as measured by Edwards "Flotrac" sensor.
Primary Outcome Measure Information:
Title
Time weighted average of area under hypotensive threshold
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Cumulative duration of hypotension
Time Frame
During surgery
Title
Number of hypotensive events
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
1000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will share anonymized data after article publication
Learn more about this trial
Use of Hypotension Prediction Index to Reduce Intraoperative Hypotension in Major Thoracic Surgery
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