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

NCT03160742 | Terminated FDA Device

• 1 other identifier: IRB-P00024295
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Central Venous Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Mespere VENUS 200CVP system DEVICE

Non-invasive sensor placed on the neck

Non-invasive monitoring

Eligibility Criteria

• Age: 12 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Mespere Lifesciences Inc.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

• Kirsten Odegard, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: April 25, 2018
• Primary Completion: April 25, 2018
• Study Completion: September 14, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)