Prediction of Hemodynamic Instability in Patients Undergoing Surgery

May 22, 2018 updated by: D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients undergoing surgery in the AMC were included in the study. Subjects were only excluded when technical problems or strong local vasoconstriction (i.e., cold fingers) prevented the Nexfin® non-invasive blood pressure finger cuff measurement. Subjects were not excluded for any other reason besides technical failure.

Description

Inclusion Criteria:

  • all adult patients undergoing surgery

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity of the HPI algorithm
Time Frame: three minutes prior to the hypotensive event
Sensitivity
three minutes prior to the hypotensive event
Specifity of the HPI algorithm
Time Frame: three minutes prior to the hypotensive event
Specifity
three minutes prior to the hypotensive event

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictive positive value of the HPI algorithm
Time Frame: one minute prior to the hypotensive event
Predictive positive value
one minute prior to the hypotensive event
Predictive positive value of the HPI algorithm
Time Frame: two minutes prior to the hypotensive event
Predictive positive value
two minutes prior to the hypotensive event
Predictive positive value of the HPI algorithm
Time Frame: three minutes prior to the hypotensive event
Predictive positive value
three minutes prior to the hypotensive event
Predictive positive value of the HPI algorithm
Time Frame: four minutes prior to the hypotensive event
Predictive positive value
four minutes prior to the hypotensive event
Predictive positive value of the HPI algorithm
Time Frame: five minutes prior to the hypotensive event
Predictive positive value
five minutes prior to the hypotensive event
Predictive positive value of the HPI algorithm
Time Frame: ten minutes prior to the hypotensive event
Predictive positive value
ten minutes prior to the hypotensive event
Predictive positive value of the HPI algorithm
Time Frame: 15 minutes prior to the hypotensive event
Predictive positive value
15 minutes prior to the hypotensive event
Negative predictive value of the HPI algorithm
Time Frame: one minute prior to the hypotensive event
Negative predictive value
one minute prior to the hypotensive event
Negative predictive value of the HPI algorithm
Time Frame: two minutes prior to the hypotensive event
Negative predictive value
two minutes prior to the hypotensive event
Negative predictive value of the HPI algorithm
Time Frame: four minutes prior to the hypotensive event
Negative predictive value
four minutes prior to the hypotensive event
Negative predictive value of the HPI algorithm
Time Frame: five minutes prior to the hypotensive event
Negative predictive value
five minutes prior to the hypotensive event
Negative predictive value of the HPI algorithm
Time Frame: ten minutes prior to the hypotensive event
Negative predictive value
ten minutes prior to the hypotensive event
Negative predictive value of the HPI algorithm
Time Frame: 15 minutes prior to the hypotensive event
Negative predictive value
15 minutes prior to the hypotensive event
Time from HPI alarm to hypotensive event during surgery
Time Frame: 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.
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)
Sensitivity of the HPI algorithm
Time Frame: one minute prior to the hypotensive event
Sensitivity
one minute prior to the hypotensive event
Sensitivity of the HPI algorithm
Time Frame: two minutes prior to the hypotensive event
Sensitivity
two minutes prior to the hypotensive event
Sensitivity of the HPI algorithm
Time Frame: five minutes prior to the hypotensive event
Sensitivity
five minutes prior to the hypotensive event
Sensitivity of the HPI algorithm
Time Frame: ten minutes prior to the hypotensive event
Sensitivity
ten minutes prior to the hypotensive event
Sensitivity of the HPI algorithm
Time Frame: 15 minutes prior to the hypotensive event
Sensitivity
15 minutes prior to the hypotensive event
Specifity of the HPI algorithm
Time Frame: one minute prior to the hypotensive event
Specifity
one minute prior to the hypotensive event
Specifity of the HPI algorithm
Time Frame: two minutes prior to the hypotensive event
Specifity
two minutes prior to the hypotensive event
Specifity of the HPI algorithm
Time Frame: five minutes prior to the hypotensive event
Specifity
five minutes prior to the hypotensive event
Specifity of the HPI algorithm
Time Frame: ten minutes prior to the hypotensive event
Specifity
ten minutes prior to the hypotensive event
Specifity of the HPI algorithm
Time Frame: 15 minutes prior to the hypotensive event
Specifity
15 minutes prior to the hypotensive event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W15_080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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