Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU

Surgery Clinical Trial

— Capstesia  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03727503
• Other study ID #: P2018/487
• Status: Terminated
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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.

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPV measure	PPV before with after 2 maneuvers which modify PPV (increase PEEP level and mini-fluid challenge)	baseline
Primary	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