Validation of CardioQ Versus PiCCO in Children

Radboud University Medical Center11 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiac Output

Interventions

CardioQDEVICE

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Radboud Univeristy Medical Center

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

cardiac output

liter/m2/minute

Time frame: 24 hours

stroke volume

milliliters

Time frame: 24 hours

Secondary Outcomes

flow time corrected

seconds

Time frame: 24 hours

stroke distance

centimeters

Time frame: 24 hours

Data from ClinicalTrials.gov

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