Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Completed

• Conditions: Blood Pressure; Prediction Models; Machine Learning; Hemodynamic Instability

• Registration Number: NCT03533205
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2016-12-01
• Study Completion: 2018-04-26
• Study First Submitted: 2018-04-26
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-22
• Last Update Submitted: 2018-05-22
• Study First Posted: 2018-05-23
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 507

Inclusion Criteria

• all adult patients undergoing surgery

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the HPI algorithm	three minutes prior to the hypotensive event	Sensitivity
Specifity of the HPI algorithm	three minutes prior to the hypotensive event	Specifity

Secondary Outcome Measures

Name	Time	Method
Predictive positive value of the HPI algorithm	15 minutes prior to the hypotensive event	Predictive positive value
Negative predictive value of the HPI algorithm	15 minutes prior to the hypotensive event	Negative predictive value
Sensitivity of the HPI algorithm	15 minutes prior to the hypotensive event	Sensitivity
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)	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.
Specifity of the HPI algorithm	15 minutes prior to the hypotensive event	Specifity