Measurement of Pulse Pressure Variation and Cardiac Output by a New Application for Android™ (Captesia™)

December 6, 2016 updated by: Céline Boudart, Erasme University Hospital

Measurement of Pulse Pressure Variation (PPV) and Cardiac Output (CO) by a New Application for Android™ (Captesia™) : Comparison With PPV and CO Obtained by a Method of Transpulmonary Thermodilution.

This study test the agreement and accuracy of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against the gold standard : PPV and CO calculated by thermodilution.

Study Overview

Status

Completed

Conditions

Detailed Description

Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the OR. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bruxelles, Belgium, 1070
        • Erasme Hospital

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

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

patients scheduled for coronary artery bypass

Description

Inclusion Criteria:

  • patients scheduled for coronary artery bypass

Exclusion Criteria:

  • patients with arrhythmias like atrial fibrillation
  • patients with valvular insufficiency

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

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PPV
This study will track changes in PPV and CO before and after of volume expansion, which goal is to change the cardiac output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPV
Time Frame: at time of surgery
the Pulse Pressure Variation will be calculated by the Android Application (Captesia) and by the Picco before and after a meneuver of volume expansion, which goal is to change the cardiac output.
at time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CO
Time Frame: at time of surgery
the Cardiac Output will be calculated by the Android Application (Captesia) and by thermodilution before and after of volume expansion, which goal is to change the cardiac output.
at time of surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Céline F Boudart, MD, Erasme Hospital Bruxelles
  • Principal Investigator: Alexandre Joosten, MD, Erasme Hospital Bruxelles

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.

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

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 22, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • B406201526827

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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