Validation of CardioQ Versus PiCCO in Children (CQPiCCO)

Radboud University Medical Center

Status: Enrolling

Conditions: Cardiac Output

Treatments: Device: CardioQ

Study type: Interventional

Funder types: Other

Identifiers

NCT03172689

NL57824.091.16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

CardioQ

Other group

Description:

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

Treatment:

Device: CardioQ