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

Central Venous Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03160742
• Other study ID #: IRB-P00024295
• Status: Terminated
• Start date: April 25, 2018
• Est. completion date: September 14, 2018

Study information

• Verified date: October 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 14, 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Pressure

Intervention

Device:
• Mespere VENUS 200CVP system
Non-invasive sensor placed on the neck

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Mespere Lifesciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.