Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03727503
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Alexandre Joosten, Erasme University Hospital

Tracking Information
First Submitted Date  ICMJE October 29, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • PPV measure [ Time Frame: baseline ]
    PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03727503 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU
Official Title  ICMJE Ability of a New PPV Smartphone Application to Predict Fluid Responsiveness in Cardiac Surgical Patients in the ICU
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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Surgery
Intervention  ICMJE 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.
Study Arms  ICMJE group/cohort
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.
Intervention: Other: PPV from the capstesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandre Joosten, M.D 025553111 ext 025553111 joosten-alexandre@hotmail.com
Contact: EGO AMEDEE, M.D 025553111 ext 025553111 amede-ego@hotmail.com
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03727503
Other Study ID Numbers  ICMJE P2018/487
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alexandre Joosten, Erasme University Hospital
Study Sponsor  ICMJE Erasme University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandre Joosten, M.D ERASME
PRS Account Erasme University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP