Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring (Capstesia)

Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring.

This study test the agreement and precision of Pulse Pressure Variation (PPV) and Cardiac Output (CO) obtained by the Android application Capstesia™ against another pulse contour CO monitoring ( EV-1000, Edwards Lefesciences, USA)

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Device: Capstesia

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): 40

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme

Participation Criteria

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 major surgery

Description

Inclusion Criteria:

• patients scheduled for major surgery which requires a CO and PPV monitoring as standard of care

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement and precision of PPV and CO during 5 surgical phases (postinduction, pre incision, postincision, end of surgery and at least one episode of hypotension)	We will compare PPV and CO given with the EV-1000 and the capstesia app at different phases of the surgery	during surgery

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Publications and helpful links

General Publications

• Joosten A, Jacobs A, Desebbe O, Vincent JL, Sarah S, Rinehart J, Van Obbergh L, Hapfelmeier A, Saugel B. Monitoring of pulse pressure variation using a new smartphone application (Capstesia) versus stroke volume variation using an uncalibrated pulse wave analysis monitor: a clinical decision making study during major abdominal surgery. J Clin Monit Comput. 2019 Oct;33(5):787-793. doi: 10.1007/s10877-018-00241-4. Epub 2019 Jan 3.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 23, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: P2017/224 / B406201731906

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