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

Terminated

• Conditions: Central Venous Pressure
• Interventions: Device: Mespere VENUS 200CVP system

• Registration Number: NCT03160742
• Lead Sponsor: Boston Children's Hospital

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).

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2018-04-25
• Primary Completion: 2018-04-25
• Study Completion: 2018-09-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-invasive monitoring	Mespere VENUS 200CVP system	In addition to standard monitoring, the Mespere VENUS 200CVP system will be used to record central venous pressures.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States