Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: ezCVP measurement.
- Кому может быть актуально
- Состояния в реестре: Congestive Heart Failure. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Pilot Study for the Evaluation of EzCVP in Heart Failure Patients
Обзор
Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission
Подробное описание
Determining the degree of congestion is important in deciding appropriate timing for discharging hospitalized heart failure patients. Central venous pressure (CVP) reflects the returning blood volume to the heart and can guide therapy to relieve congestion. However, the conventional method used to measure CVP has notable limitations as it is an invasive procedure that requires placement of a central venous catheter.
Traditional, non-invasive methods of estimating CVP, such as physical examination and echocardiogram, are less accurate and more resource intensive. To overcome this challenge, new technology to assess CVP non-invasively using an oscillometric method has been developed. This new technology involves measurement of the enclosed zone central venous pressure (ezCVP), which, in a preclinical study, has been shown to correlate with invasive data.
Additionally, a previous correlation study demonstrated that the ezCVP value can be mathematically adjusted to estimate invasive CVP. The resulting value has been termed CVPNI (CVP Non-Invasive). Most recently, a limited pilot study of patients hospitalized with acute, decompensated heart failure demonstrated the feasibility of device use in this population and the expected and incremental fall in CVPNI with medical treatment over the course of hospitalization.
Moving forward, and in order to further improve the care of patients hospitalized with heart failure, an expanded pilot study of ezCVP technology is needed to prove that changes in CVPNI track with these patients' condition during admission and can be useful in their clinical care.
Вмешательства
- Устройство ezCVP measurement
* Measuring device: non-FDA-cleared patient monitor (740E, Zoe Medical, MA, US), which has software to measure ezCVP. * Sensor: an FDA-cleared pulse oximeter sensor for adults (K012891: DS-100A, Nellcor, CA, US). * Cuff: an FDA-cleared NIBP cuff for adults (K080342: YP-713T, YP-714T or TP-715T, Nihon Kohden Corporation, Tokyo, Japan).
Первичные конечные точки
- Evaluate the difference between non-invasive CVP measurement at admission and at discharge [Срок оценки: 7 days]
- Evaluate the difference between non-invasive CVP measurement in right and left arms [Срок оценки: 7 days]
Вторичные конечные точки (4)
- Evaluate the relationship between CVPNI at discharge and readmission rate [Срок оценки: 100 days]
- Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization [Срок оценки: 7 days]
- Compare changes in CVPNI to changes in KCCQ quality scores [Срок оценки: 21 days]
- Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects [Срок оценки: 100 days]
Критерии участия
Критерии включения
- Arm circumference of 23 cm to 55 cm
- Subject admitted to the hospital with acute exacerbation of heart failure, with either reduced or preserved ejection fraction
- Subject is at risk for readmission (NYHA Functional Classification 2-3)
- Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written, informed consent
- ezCVP indicator is high (CVPNI is over 9 mmHg) at admission
- Subject is willing and able to comply with protocol procedures
- Subject tested negative for COVID test after admission to the hospital
Критерии исключения
- Finger and upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff
- Pregnant (self-reported)
- Upper extremity DVT (currently being treated)
- Severe skin disease involving the upper arm(s)
- Study investigator may exclude patients based on clinical judgement
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 2 центра
- Veterans Affairs Hospital — Palo Alto
- Stanford Medical Center — Stanford
Идентификаторы
NCT: NCT05441696 · 70Ag_Ogino-00026