Evaluation of the Argos System to Estimate Cardiac Output
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluid bolus, Norepinephrine.
- Who it may be relevant to
- Registry conditions: Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Argos System to Estimate Cardiac Output in Critically Ill Patients
Overview
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.
Detailed description
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.
Interventions
- Drug Fluid bolus
Giving a fluid bolus of 500mL of normal saline (NaCl 0.9%) - Drug Norepinephrine
brief, transient increase in norepinephrine to achieve a 15mmHg increase in mean arterial pressure and evaluates if tissue perfusion improves
Primary outcome measures
- 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. [Time frame: 1 hour (before and after intervention)]
Secondary outcome measures (2)
- Accuracy of the Argos system [Time frame: 1 hour (before and after intervention)]
- Precision of the Argos system [Time frame: 1 hour (before and after intervention)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Bicêtre Hospital — Le Kremlin-Bicêtre
Identifiers
NCT: NCT07724262 · Argos study · CE-SRLF 24-100