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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-25

Study Completion Date

2018-09-14

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).

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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).

Conditions

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Central Venous Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-invasive monitoring

In addition to standard monitoring, the Mespere VENUS 200CVP system will be used to record central venous pressures.

Mespere VENUS 200CVP system

Intervention Type DEVICE

Non-invasive sensor placed on the neck

Interventions

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Mespere VENUS 200CVP system

Non-invasive sensor placed on the neck

Intervention Type DEVICE

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

Minimum Eligible Age

12 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No