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

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).

Study Overview

• Status: Terminated
• Conditions: Central Venous Pressure
• Intervention / Treatment: Device: Mespere VENUS 200CVP system

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-invasive monitoring; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Mespere Lifesciences Inc.
• Investigators: Principal Investigator: Kirsten Odegard, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): April 25, 2018
• Study Completion (Actual): September 14, 2018

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00024295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No