Skip to main content
OpenTrials
Completed

NCT Number: NCT05615168

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypotension During Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Dubrava

Zagreb, City of Zagreb, 1000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Acumen IQ" guided hemodynamic optimization

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" guided hemodynamic optimization

Diagnostic Test

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

Primary outcomes

  1. Time weighted average of area under hypotensive threshold

    Time frame: During surgery

Secondary outcomes

  1. Cumulative duration of hypotension

    Time frame: During surgery

  2. Number of hypotensive events

    Time frame: During surgery

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.