Central Venous Pressure
Conditions
Brief summary
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
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).
Interventions
DEVICEMespere VENUS 200CVP system
Non-invasive sensor placed on the neck
Sponsors
Mespere Lifesciences Inc.
Boston Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Months to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Mespere VENUS 2000CVP | The data will be collected for the length of the cardiac surgery, up to 6 hours. | 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. |
Countries
United States
Outcome results
None listed