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Clinical Trials/NCT05615168
NCT05615168
Completed
N/A

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

University Hospital Dubrava1 site in 1 country34 target enrollmentJanuary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypotension During Surgery
Sponsor
University Hospital Dubrava
Enrollment
34
Locations
1
Primary Endpoint
Time weighted average of area under hypotensive threshold
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
August 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Dubrava
Responsible Party
Principal Investigator
Principal Investigator

Andrej Šribar

Prinicipal investigator, Head of division of cardiovascular anesthesiology

University Hospital Dubrava

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time weighted average of area under hypotensive threshold

Time Frame: During surgery

Secondary Outcomes

  • Number of hypotensive events(During surgery)
  • Cumulative duration of hypotension(During surgery)

Study Sites (1)

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