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

Surgery Clinical Trial

— Capstesia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137901
• Other study ID #: P2017/224 / B406201731906
• Status: Completed
• Start date: May 10, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Capstesia
Picture of the arterial waveform taken with a smartphone

Locations

Country	Name	City	State
Belgium	Erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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