A Clinical Study Used to Estimate Central Venous Pressure Non-invasively Using Occlusion Pressure

NCT07583680 | Not Yet Recruiting

• 1 other identifier: 25-10829-FB: CV-PRO
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to collect different measurements using a method called peripheral venous pressure (PVP). PVP checks the pressure in the veins in the arms or legs. It can give doctors a good idea of how well the heart is working, similar to another method called central venous pressure (CVP), which doctors use in hospitals. In this study, the research team will measure PVP in people aged 0-17. The researcher hopes that this data will help doctors understand how PVP measurements relate to health outcomes, which could lead to better ways to diagnose and treat patients in the future. The peripheral venous pressure (PVP) device will be used to non-invasively measure the pressure required to stop blood flow in the forearm, which will indirectly measure the PVP in the forearm. This device is composed of a pressure sensor and a Doppler flow detector that will be connected to a research laptop for data collection. This device will be placed on the forearm. If you agree to be in this study, the study team will monitor the venous flow rate (the amount of blood moving through the veins over a certain period of time) using a Doppler Flow Detector while applying pressure to the vein with a pressure sensor. This will take place on the forearm. The internal jugular vein will be identified and recorded using ultrasound imaging and Doppler sensor. The forearm vein will be identified and marked using ultrasound imaging. Pressure will be applied for 15 seconds, and then stopped and repeated 4 times, making five sets of measurements. The procedure may be repeated in 2-3 additional sessions during the hospital stay, if necessary. Your participation in this study will last approximately 30 minutes. This procedure is for research only and will not affect your regular care. This will occur during your child's stay in the PCICU/PICU. No additional study visits will be required. The following procedures are being performed for research purposes only: Copying information such as your medical history from your medical record; Obtaining non-invasive peripheral venous pressure measurements.

Conditions

Congestive Heart Failure; Pediatric Congestive Heart Failure

Keywords

CHF; Pediatric CHF; Congenital Heart Disease; Pediatric Congenital Heart Disease; Pediatric Congestive Heart Failure; Congestive Heart Failure; Heart Failure; CVP; Central Venous Pressure; CVP Monitor

Outcome Measures

Primary Outcomes (1)

• Mean absolute error (MAE) between non-invasive estimated central venous pressure (Doppler-coupled occlusion-pressure device) and invasive central venous pressure (central venous catheter)

  Unit of Measure: mmHg For each participant, the non-invasive estimated CVP value derived from the Doppler-coupled occlusion-pressure measurement (5 technical replicates per session) will be compared to the simultaneous invasive CVP value obtained from the central venous catheter (standard of care). The primary reportable outcome is the MAE across participants, defined as the mean of the absolute difference between paired estimated and measured CVP values, expressed in mmHg. The pre-specified target is MAE ≤ 2 mmHg, consistent with the sample-size justification (n=25 to achieve 80% power assuming an acceptable margin of error of 2 mmHg, a Type I error rate of 5%, and an expected standard deviation of 4 mmHg from prior literature). Intermediate algorithm inputs including vein-occlusion pressure, initial vein diameter, Doppler-isolated venous waveform characteristics, internal jugular vein Doppler recording, and intrapatient and interpatient variability of device output.

  At time of single study session, up to 60 minutes

Secondary Outcomes (1)

• Correlation between non-invasive estimated central venous pressure and invasive central venous pressure, adjusted for concurrent physiologic context variables abstracted from the electronic medical record

  At time of single study session, up to 60 minutes

Study Arms (2)

Pediatric Participants Admitted to the ICU with a Central Venous Catheter

All participants in the study admitted to a pediatric ICU with a central venous catheter in place.

Variable CVP Subset

A subset of approximately 5 participants that have varying ranges of central venous pressure throughout their hospitalization.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) or the Pediatric Cardiac Intensive Care Unit (PCICU) at Le Bonheur Children's Hospital.

You may qualify if:

• Admitted to PICU or PCICU
• Provided written informed consent
• Continuous Central venous pressure monitoring transduced from a standard central venous catheter (not PICC line)

You may not qualify if:

• Glenn and Fontan Patients
• Heterotaxy Syndrome Patients
• Inability to consent by guardian/caretaker

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead
• The Brett Boyer Foundation: collaborator

MeSH Terms

Conditions

Heart Failure; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiac Surgeon

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05