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

NCT ID: NCT03137901

Last Updated: 2019-11-26

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-10

Study Completion Date

2017-06-30

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Capstesia

Picture of the arterial waveform taken with a smartphone

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Joosten, MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre Joosten, M.D

Role: PRINCIPAL_INVESTIGATOR

Erasme

Locations

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Erasme

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 30607806 (View on PubMed)

Other Identifiers

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P2017/224 / B406201731906

Identifier Type: -

Identifier Source: org_study_id

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