A Clinical Study Used to Estimate Central Venous Pressure Non-invasively Using Occlusion Pressure (CV-PRO)
Non-Invasive Central Venous Pressure Estimation Using Occlusion Pressure: A Novel Approach for Accurate Hemodynamic Monitoring
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Admitted to PICU or PCICU
- Provided written informed consent
- Continuous Central venous pressure monitoring transduced from a standard central venous catheter (not PICC line)
Exclusion Criteria:
- Glenn and Fontan Patients
- Heterotaxy Syndrome Patients
- Inability to consent by guardian/caretaker
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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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.
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Variable CVP Subset
A subset of approximately 5 participants that have varying ranges of central venous pressure throughout their hospitalization.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean absolute error (MAE) between non-invasive estimated central venous pressure (Doppler-coupled occlusion-pressure device) and invasive central venous pressure (central venous catheter)
Časové okno: At time of single study session, up to 60 minutes
|
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.
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At time of single study session, up to 60 minutes
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: At time of single study session, up to 60 minutes
|
Unit of Measure: Pearson correlation coefficient (r), unitless, range -1.00 to +1.00 Strength of the linear association between the non-invasive estimated CVP (Doppler-coupled occlusion-pressure device) and simultaneous invasive CVP (central venous catheter).
The regression model will adjust for concurrent physiologic context variables abstracted from the EMR at the single study session - collected as standard of care, with no extra research procedures: heart rate, cardiac rhythm, respiratory rate, non-invasive and arterial-line blood pressure (systolic, diastolic, MAP), SpO2, ETCO2, awRR, mixed venous oxygen saturation, stroke volume, cardiac output, and intracardiac chamber pressures.
Only readily available EMR parameters will be recorded; no procedures will be added to obtain missing data.
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At time of single study session, up to 60 minutes
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25-10829-FB: CV-PRO
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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