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Clinical Trials/NCT03533205
NCT03533205
Completed
N/A

Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Overview

Phase
N/A
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
507
Primary Endpoint
Sensitivity of the HPI algorithm
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2015
End Date
April 26, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

D.P.Veelo

MD PhD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • all adult patients undergoing surgery

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 Outcomes

  • Predictive positive value of the HPI algorithm(15 minutes prior to the hypotensive event)
  • Negative predictive value of the HPI algorithm(15 minutes prior to the hypotensive event)
  • Sensitivity of the HPI algorithm(15 minutes prior to the hypotensive event)
  • Time from HPI alarm to hypotensive event during surgery(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))
  • Specifity of the HPI algorithm(15 minutes prior to the hypotensive event)

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