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Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03533205
Enrollment
507
Registered
2018-05-23
Start date
2015-04-01
Completion date
2018-04-26
Last updated
2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Hemodynamic Instability, Machine Learning, Prediction Models

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.

Interventions

DIAGNOSTIC_TESTHypotension 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* all adult patients undergoing surgery

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of the HPI algorithmthree minutes prior to the hypotensive eventSensitivity
Specifity of the HPI algorithmthree minutes prior to the hypotensive eventSpecifity

Secondary

MeasureTime frameDescription
Time from HPI alarm to hypotensive event during surgeryFrom 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.
Predictive positive value of the HPI algorithmone minute prior to the hypotensive eventPredictive positive value
Specifity of the HPI algorithmone minute prior to the hypotensive eventSpecifity
Sensitivity of the HPI algorithmone minute prior to the hypotensive eventSensitivity
Negative predictive value of the HPI algorithmone minute prior to the hypotensive eventNegative predictive value

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026