Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Blood Pressure Clinical Trial

Official title:

Prediction of Hemodynamic Instability in Patients Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533205
• Other study ID #: W15_080
• Status: Completed
• Start date: April 1, 2015
• Est. completion date: April 26, 2018

Study information

• Verified date: May 2018
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: April 26, 2018
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all adult patients undergoing surgery

Exclusion Criteria:

Related Conditions & MeSH terms

• Blood Pressure
• Hemodynamic Instability
• Machine Learning
• Prediction Models

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the HPI algorithm	Sensitivity	three minutes prior to the hypotensive event
Primary	Specifity of the HPI algorithm	Specifity	three minutes prior to the hypotensive event
Secondary	Predictive positive value of the HPI algorithm	Predictive positive value	one minute prior to the hypotensive event
Secondary	Predictive positive value of the HPI algorithm	Predictive positive value	two minutes prior to the hypotensive event
Secondary	Predictive positive value of the HPI algorithm	Predictive positive value	three minutes prior to the hypotensive event
Secondary	Predictive positive value of the HPI algorithm	Predictive positive value	four minutes prior to the hypotensive event
Secondary	Predictive positive value of the HPI algorithm	Predictive positive value	five minutes prior to the hypotensive event
Secondary	Predictive positive value of the HPI algorithm	Predictive positive value	ten minutes prior to the hypotensive event
Secondary	Predictive positive value of the HPI algorithm	Predictive positive value	15 minutes prior to the hypotensive event
Secondary	Negative predictive value of the HPI algorithm	Negative predictive value	one minute prior to the hypotensive event
Secondary	Negative predictive value of the HPI algorithm	Negative predictive value	two minutes prior to the hypotensive event
Secondary	Negative predictive value of the HPI algorithm	Negative predictive value	four minutes prior to the hypotensive event
Secondary	Negative predictive value of the HPI algorithm	Negative predictive value	five minutes prior to the hypotensive event
Secondary	Negative predictive value of the HPI algorithm	Negative predictive value	ten minutes prior to the hypotensive event
Secondary	Negative predictive value of the HPI algorithm	Negative predictive value	15 minutes prior to the hypotensive event
Secondary	Time from HPI alarm to hypotensive event during surgery	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.	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)
Secondary	Sensitivity of the HPI algorithm	Sensitivity	one minute prior to the hypotensive event
Secondary	Sensitivity of the HPI algorithm	Sensitivity	two minutes prior to the hypotensive event
Secondary	Sensitivity of the HPI algorithm	Sensitivity	five minutes prior to the hypotensive event
Secondary	Sensitivity of the HPI algorithm	Sensitivity	ten minutes prior to the hypotensive event
Secondary	Sensitivity of the HPI algorithm	Sensitivity	15 minutes prior to the hypotensive event
Secondary	Specifity of the HPI algorithm	Specifity	one minute prior to the hypotensive event
Secondary	Specifity of the HPI algorithm	Specifity	two minutes prior to the hypotensive event
Secondary	Specifity of the HPI algorithm	Specifity	five minutes prior to the hypotensive event
Secondary	Specifity of the HPI algorithm	Specifity	ten minutes prior to the hypotensive event
Secondary	Specifity of the HPI algorithm	Specifity	15 minutes prior to the hypotensive event