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

Ability of a New PPV Smartphone Application to Predict Fluid Responsiveness in Cardiac Surgical Patients in the ICU

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)

Study Overview

• Status: Terminated
• Conditions: Surgery
• Intervention / Treatment: Other: PPV from the capstesia

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPV measure	PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)	baseline
PPV measure	PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)	1 minute after the end of volume expansion

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2019
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (ACTUAL): November 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: P2018/487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No