Validation of CardioQ Versus PiCCO in Children

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2024-02-01

Brief Summary

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To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.

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Detailed Description

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This is a validation study. The study period starts as soon as CMO approval is acquired and will end after inclusion of 17 patients. This study is designed to test the effectiveness of a non invasive ODM catheter compared to the invasive, gold standard, TPTD technique.

Conditions

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Cardiac Output

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

children with an clinical indication for cardiac output monitoring in ICU or OR

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CardioQ

CardioQ will be used as CO monitor simultaneously with the standard of care PiCCO CO monitor

Group Type OTHER

CardioQ

Intervention Type DEVICE

comparison of cardiac output measurements between gold standard transpulmonary thermodilution (by PiCCO) versus an oesophageal doppler monitor (CardioQ) They will be used simultaneously

Interventions

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CardioQ

comparison of cardiac output measurements between gold standard transpulmonary thermodilution (by PiCCO) versus an oesophageal doppler monitor (CardioQ) They will be used simultaneously

Intervention Type DEVICE

Other Intervention Names

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PiCCO

Eligibility Criteria

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Inclusion Criteria

* Patients aged 0 to 16 years with an indication for invasive CO monitoring (TPTD). Indication for invasive CO monitoring always implies intubation and sedation.
* Signed informed consent

Exclusion Criteria

* Congenital or acquired cardiovascular diseases (intracardiac/extracardiac intrathoracic shunt
* Cardiac valve diseases
* Aortic arch anomalies
* Tissue necrosis of oesophagus
* Carcinoma of pharynx, larynx of oesophagus
* Severe bleeding diatheses
* Age \> 16 years
* Weight \< 3.5 kg or \> 50 kg.

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No