Prediction of Hemodynamic Instability in Patients Undergoing Surgery

NCT ID: NCT03533205

Last Updated: 2018-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

507 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-01

Study Completion Date

2018-04-26

Brief Summary

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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

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Conditions

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Blood Pressure Prediction Models Machine Learning Hemodynamic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* all adult patients undergoing surgery

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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D.P.Veelo

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Wijnberge M, van der Ster BJP, Geerts BF, de Beer F, Beurskens C, Emal D, Hollmann MW, Vlaar APJ, Veelo DP. Clinical performance of a machine-learning algorithm to predict intra-operative hypotension with noninvasive arterial pressure waveforms: A cohort study. Eur J Anaesthesiol. 2021 Jun 1;38(6):609-615. doi: 10.1097/EJA.0000000000001521.

Reference Type DERIVED
PMID: 33927105 (View on PubMed)

Other Identifiers

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W15_080

Identifier Type: -

Identifier Source: org_study_id

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