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Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU (Capstesia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03727503
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : April 1, 2019
Information provided by (Responsible Party):
Alexandre Joosten, Erasme University Hospital

Brief Summary:
The goal of this study is to assess the ability of a new smartphone PPV app to predict fluid responsiveness in cardiac surgical patients in the Intensive care unit (in the postoperative period)

Condition or disease Intervention/treatment Phase
Surgery Other: PPV from the capstesia Not Applicable

Detailed Description:
Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the ICU in ventilated and sedated patients. 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 often costly 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Agreement and precision between two methods to measure pulse pressure variation (PPV)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ability of a New PPV Smartphone Application to Predict Fluid Responsiveness in Cardiac Surgical Patients in the ICU
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
operated patients from cardiac surgery. Once they arrived in the ICU, we will measure PPV with the capstesia and the PICCO device at baseline, and after a volume expansion of 500 ml of crystalloid.
Other: PPV from the capstesia
we will challenge the application by doing 2 maneuvers: the first one is to increase the PEEP level from 5 to 15 cmH2O and the second one is the infusion of a mini-fluid challenge (100 ml) followed by the other 400 ml.

Primary Outcome Measures :
  1. PPV measure [ Time Frame: baseline ]
    PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)

  2. PPV measure [ Time Frame: 1 minute after the end of volume expansion ]
    PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adults patients ( >18 years)
  • Patients scheduled for cardiac surgery
  • equipped with a femoral arterial catheter and the PICCO device

Exclusion Criteria:

  • Atrial fibrillation
  • severe cardiac dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03727503

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Contact: Alexandre Joosten, M.D 025553111 ext 025553111
Contact: EGO AMEDEE, M.D 025553111 ext 025553111

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Erasme Hospital Recruiting
Brussels, Belgium, 1070
Contact: Alexandre Joosten, MD PhD    025553111 ext 025553111   
Sponsors and Collaborators
Erasme University Hospital
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Principal Investigator: Alexandre Joosten, M.D ERASME

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Responsible Party: Alexandre Joosten, Principal Investigator, Erasme University Hospital Identifier: NCT03727503    
Other Study ID Numbers: P2018/487
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No