An observational study in Central Venous Pressure, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged 12 Months to 10 Years. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Boston Children's Hospital · Observational
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).
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).
Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
30 children ages 12 months to 10.9 years scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital.
Exclusion Criteria:
In addition to standard monitoring, the Mespere VENUS 200CVP system will be used to record central venous pressures.
Device: Mespere VENUS 200CVP system
Non-invasive sensor placed on the neck
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.
Time frame: The data will be collected for the length of the cardiac surgery, up to 6 hours.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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