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NCT05615168 Clinical Trial

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

Hypotension During Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05615168
Other study ID # 2022/1807-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date August 30, 2022

Study information
Verified date November 2022
Source University Hospital Dubrava
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date August 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Croatia University Hospital Dubrava Zagreb Grad Zagreb

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time weighted average of area under hypotensive threshold During surgery
Secondary Cumulative duration of hypotension During surgery
Secondary Number of hypotensive events During surgery
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