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

Официальное название

Non-Invasive Central Venous Pressure Estimation Using Occlusion Pressure: A Novel Approach for Accurate Hemodynamic Monitoring

Обзор

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.

Подробное описание

Pediatric congestive heart failure (CHF) is a complex, often end-stage condition affecting around 35,000 children annually in the U.S., with 14,000 hospitalizations and a 6.3% in-hospital mortality rate. CHF occurs when the heart can't meet circulatory demands, leading to increased central venous pressure (CVP), which is currently measured invasively.

In outpatient pediatric care, CHF monitoring relies on subjective symptom reporting and potentially inaccurate weight measurements resulting in a 50% misdiagnosis rate. Recent studies indicate a strong correlation between peripheral venous pressure (PVP) and CVP, suggesting that noninvasive PVP measurements, obtained through occlusion pressure, could accurately estimate CVP.

To test this, the researcher developed a proof-of-concept study using ultrasound, Doppler transducers, and pressure sensors to measure occlusion pressure in veins. This data will be calibrated against direct CVP measurements from central lines using linear regression. The goal is to enhance outpatient monitoring for pediatric CHF, improving diagnostic accuracy by integrating inpatient methods into outpatient settings.

This study will push forward the development of an innovation in pediatric outpatient monitoring, aiming to bring the accuracy and precision of inpatient monitoring into the outpatient settings.

Первичные конечные точки

• Mean absolute error (MAE) between non-invasive estimated central venous pressure (Doppler-coupled occlusion-pressure device) and invasive central venous pressure (central venous catheter) [Срок оценки: At time of single study session, up to 60 minutes]

Вторичные конечные точки (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 [Срок оценки: At time of single study session, up to 60 minutes]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07583680 · 25-10829-FB: CV-PRO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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