Agreement and Precision of Capstesia, a New Smarphone Application for PPV and CO Monitoring
Capstesia
1 other identifier
observational
40
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedStudy Start
First participant enrolled
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedNovember 26, 2019
November 1, 2019
2 months
April 19, 2017
November 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Picture of the arterial waveform taken with a smartphone
Eligibility Criteria
patients scheduled for major surgery
You may qualify if:
- patients scheduled for major surgery which requires a CO and PPV monitoring as standard of care
You may not qualify if:
- patients with arrhythmias like atrial fibrillation
- patients with valvular insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasme
Brussels, 1070, Belgium
Related Publications (1)
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.
PMID: 30607806DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Joosten, M.D
Erasme
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 19, 2017
First Posted
May 3, 2017
Study Start
May 10, 2017
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
November 26, 2019
Record last verified: 2019-11