Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children

Study Overview
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Brief Summary
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The goal of this research study is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).

Detailed Description
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Central venous pressure (CVP), also known as right atrial pressure (RAp), is a reflection of the right heart filling pressure i.e the preload of the right ventricle. Assessment of the CVP is essential in the management of different clinical situations in children. Invasive CVP monitoring by placement of a CVP catheter either in the internal jugular vein or the subclavian vein is the gold standard way of measuring the CVP both in children and adults. However, placing a CVP catheter in a child can be challenging, time consuming, often requires the child to be sedated and it is not without complications. Being able to reliably measure the CVP noninvasively would be of great benefit for sick children as it may allow diagnoses to be made quickly and help guide treatment. The goal of this proposal is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).

Official Title
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Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children

Conditions
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Central Venous Pressure

Intervention / Treatment
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* Device: Mespere VENUS 200CVP system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 months of age to 10.9 years of age Scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital Exclusion Criteria: undergo a procedure that does not require a central venous pressure catheter as part of routine monitoring Have a known venous occlusion or any other reason the central venous pressure may be unreliable Allergy to medical grade adhesives or have any pre-existing skin irritation/eczema at the sensor site Emergently scheduled procedures

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-invasive monitoring<br>In addition to standard monitoring, the Mespere VENUS 200CVP system will be used to record central venous pressures. | Device: Mespere VENUS 200CVP system<br>* Non-invasive sensor placed on the neck<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Mespere VENUS 2000CVP | The correlation between the non-invasive measurements from the Mespere VENUS 2000CVP system and the invasive central venous pressure measurements that are continuously collected as standard of care. | The data will be collected for the length of the cardiac surgery, up to 6 hours. |