- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02692222
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
Intervention / Treatment
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
-
-
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Bruxelles, Belgium, 1070
- Erasme Hospital
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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.
Sponsor
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.
General Publications
- Yang X, Du B. Does pulse pressure variation predict fluid responsiveness in critically ill patients? A systematic review and meta-analysis. Crit Care. 2014 Nov 27;18(6):650. doi: 10.1186/s13054-014-0650-6.
- Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
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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