Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Overview

Intraoperative hypotension occurs often and is associated with adverse patient outcomes such as stroke, myocardial infarction and renal injury. The aim of this study was to test the accuracy of a physiology-based machine-learning algorithm using continuous non-invasive measurement of the blood pressure waveform with the Nexfin® finger cuff during surgery.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 1, 2016

Interventions

  • Diagnostic Test: Hypotension Probability Indicator
    • The accurary of the Hypotension Probability Indicator (HPI) is tested in the created offline database. This means data was prospectively collected but the HPI algorithm was not tested prospectively but after collection in the offline database.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity of the HPI algorithm
    • Time Frame: three minutes prior to the hypotensive event
    • Sensitivity
  • Specifity of the HPI algorithm
    • Time Frame: three minutes prior to the hypotensive event
    • Specifity

Secondary Measures

  • Predictive positive value of the HPI algorithm
    • Time Frame: one minute prior to the hypotensive event
    • Predictive positive value
  • Predictive positive value of the HPI algorithm
    • Time Frame: two minutes prior to the hypotensive event
    • Predictive positive value
  • Predictive positive value of the HPI algorithm
    • Time Frame: three minutes prior to the hypotensive event
    • Predictive positive value
  • Predictive positive value of the HPI algorithm
    • Time Frame: four minutes prior to the hypotensive event
    • Predictive positive value
  • Predictive positive value of the HPI algorithm
    • Time Frame: five minutes prior to the hypotensive event
    • Predictive positive value
  • Predictive positive value of the HPI algorithm
    • Time Frame: ten minutes prior to the hypotensive event
    • Predictive positive value
  • Predictive positive value of the HPI algorithm
    • Time Frame: 15 minutes prior to the hypotensive event
    • Predictive positive value
  • Negative predictive value of the HPI algorithm
    • Time Frame: one minute prior to the hypotensive event
    • Negative predictive value
  • Negative predictive value of the HPI algorithm
    • Time Frame: two minutes prior to the hypotensive event
    • Negative predictive value
  • Negative predictive value of the HPI algorithm
    • Time Frame: four minutes prior to the hypotensive event
    • Negative predictive value
  • Negative predictive value of the HPI algorithm
    • Time Frame: five minutes prior to the hypotensive event
    • Negative predictive value
  • Negative predictive value of the HPI algorithm
    • Time Frame: ten minutes prior to the hypotensive event
    • Negative predictive value
  • Negative predictive value of the HPI algorithm
    • Time Frame: 15 minutes prior to the hypotensive event
    • Negative predictive value
  • Time from HPI alarm to hypotensive event during surgery
    • Time Frame: From the onset of the HPI alarm to the hypotensive event during surgery, this is in minutes. (this can range from 0,1 min to a high number such as 30 or even 40 minutes)
    • Time from HPI alarm to hypotensive event, this can range from 0,1 min to a high number such as 30 or even 40 minutes.
  • Sensitivity of the HPI algorithm
    • Time Frame: one minute prior to the hypotensive event
    • Sensitivity
  • Sensitivity of the HPI algorithm
    • Time Frame: two minutes prior to the hypotensive event
    • Sensitivity
  • Sensitivity of the HPI algorithm
    • Time Frame: five minutes prior to the hypotensive event
    • Sensitivity
  • Sensitivity of the HPI algorithm
    • Time Frame: ten minutes prior to the hypotensive event
    • Sensitivity
  • Sensitivity of the HPI algorithm
    • Time Frame: 15 minutes prior to the hypotensive event
    • Sensitivity
  • Specifity of the HPI algorithm
    • Time Frame: one minute prior to the hypotensive event
    • Specifity
  • Specifity of the HPI algorithm
    • Time Frame: two minutes prior to the hypotensive event
    • Specifity
  • Specifity of the HPI algorithm
    • Time Frame: five minutes prior to the hypotensive event
    • Specifity
  • Specifity of the HPI algorithm
    • Time Frame: ten minutes prior to the hypotensive event
    • Specifity
  • Specifity of the HPI algorithm
    • Time Frame: 15 minutes prior to the hypotensive event
    • Specifity

Participating in This Clinical Trial

Inclusion Criteria

  • all adult patients undergoing surgery Exclusion Criteria:

  • none

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: D.P.Veelo, MD PhD – Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)

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