Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU

NCT ID: NCT03727503

Last Updated: 2020-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-27

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Agreement and precision between two methods to measure pulse pressure variation (PPV)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

PPV from the capstesia

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Joosten, MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre Joosten, M.D

Role: PRINCIPAL_INVESTIGATOR

ERASME

Locations

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Erasme Hospital

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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P2018/487

Identifier Type: -

Identifier Source: org_study_id

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