Меню
Идёт набор NCT07724262

Evaluation of the Argos System to Estimate Cardiac Output

Наблюдательное Shock

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: Fluid bolus, Norepinephrine.
Кому может быть актуально
Состояния в реестре: Shock. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of the Argos System to Estimate Cardiac Output in Critically Ill Patients

Обзор

The goal of this observational study is to evaluate the reliability of the Argos system to track changes in cardiac output in critically ill patients. The main question it aims to answer is: Does cardiac output changes induced by fluid administration or changes in norepinephrine dosage can be tracked by the Argos system, compared to transpulmonary thermodilution device.

Подробное описание

In patients with acute circulatory failure, hemodynamic monitoring including cardiac index (CI) assessment is recommended for most severe patients. Transpulmonary thermodilution (TPTD) is one of the methods that are recommended for this purpose, in particular because it is considered as reliable in this type of patients. The PiCCO2 system (Pulsion Medical Systems, Getinge, Feldkirchen, Germany) relies on TPTD method and associate two methods to measure CI. On the one hand, TPTD is considered as one of the gold standards for CI evaluation (CITPTD). On the other hand, pulse contour analysis calculates stroke volume from the waveform of the systolic part of the arterial pressure curve (CIpwa). The way this estimation is performed and it is regularly re-evaluated differs among the devices that are available on the market. This estimation of CIpwa is calibrated when TPTD is performed. Thus, it allows a real-time pulse contour derived CI assessment, which is very precise. However, TPTD system are considered invasive, expensive and are not available in all settings.

The Argos monitor (Retia Medical, Valhalla, USA) uses the so-called multi-beat analysis (MBA) to estimate CI after analyzing the arterial pressure waveform over periods of multiple heartbeats (up to 20) and scaling CI estimations to biometric data. The algorithm estimates the theoretical central arterial blood pressure waveform using MBA, minimizing and avoiding the cofounding effect of the wave reflection phenomena. Based on this central arterial blood pressure waveform and biometric patient data, the system estimates cardiac output. The Argos monitor has a second advantage. It simply connects to the analogue output of the blood pressure signal from a compatible multi-parameter monitor and needs no additional specific pressure sensor. During cardiac surgery, the Argos monitor showed reasonable agreement and trending ability compared to the pulmonary artery catheter. However, in patients after cardiac surgery, including those with low cardiac output and arrhythmia, CI estimated by the device was not interchangeable with the continuous thermodilution method via a PAC.

The primary objective of the study is to evaluate the reliability of the Argos system to track changes of CI induced by changes in norepinephrine or fluid administration, compared to CITPTD in critically ill patients.

Вмешательства

  • Препарат Fluid bolus
    Giving a fluid bolus of 500mL of normal saline (NaCl 0.9%)
  • Препарат Norepinephrine
    brief, transient increase in norepinephrine to achieve a 15mmHg increase in mean arterial pressure and evaluates if tissue perfusion improves

Первичные конечные точки

  • To compare the changes in cardiac output provided by the Argos system induced by changes in norepinephrine or fluid bolus, compared to cardiac output provided by the transpulmonary thermodilution device in critically ill patients. [Срок оценки: 1 hour (before and after intervention)]
Вторичные конечные точки (2)
  • Accuracy of the Argos system [Срок оценки: 1 hour (before and after intervention)]
  • Precision of the Argos system [Срок оценки: 1 hour (before and after intervention)]

Критерии участия

Критерии включения

  • Age ≥18 years old
  • Hospitalisation in intensive care
  • Haemodynamic monitoring with transpulmonary thermodilution already in place
  • Hemodynamic intervention deemed necessary by the clinician in charge of the patient
  • Administration of a fluid bolus
  • Change in norepinephrine dosage or performance of a vasopressor test

Критерии исключения

  • Pregnancy
  • Other therapeutic modification during volume expansion or the vasopressor test
  • Refusal to participate by relatives of the patient or the patient himself or herself
  • Non availability of investigators

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Bicêtre Hospital — Le Kremlin-Bicêtre

Идентификаторы

NCT: NCT07724262 · Argos study · CE-SRLF 24-100

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗