- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07724262
Evaluation of the Argos System to Estimate Cardiac Output
Evaluation of the Argos System to Estimate Cardiac Output in Critically Ill Patients
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Christopher Lai, MD, PhD
- Telefonnummer: 12633816521
- E-post: christopher.lai@aphp.fr
Studiesteder
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Le Kremlin-Bicêtre, Frankrike
- Rekruttering
- Bicetre Hospital
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Ta kontakt med:
- Christopher Lai
- Telefonnummer: 2633816521
- E-post: christopher.lai@aphp.fr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Patients with shock defined by one sign of hypoperfusion:
- systolic arterial pressure <90mmHg
- mean arterial pressure <65mmHg
- prolonged capillary refill time >3 sec
- mottling score > 2
- urine output < 0.1 mL/kg/h
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
patients with shock
Patients with shock defined by one sign of hypoperfusion:
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Giving a fluid bolus of 500mL of normal saline (NaCl 0.9%)
brief, transient increase in norepinephrine to achieve a 15mmHg increase in mean arterial pressure and evaluates if tissue perfusion improves
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: 1 hour (before and after intervention)
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1 hour (before and after intervention)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Accuracy of the Argos system
Tidsramme: 1 hour (before and after intervention)
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To evaluate the accuracy of the Argos system to measure absolute values of cardiac output compared to transpulmonary thermodilution
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1 hour (before and after intervention)
|
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Precision of the Argos system
Tidsramme: 1 hour (before and after intervention)
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To evaluate the precision and least significant change of cardiac output provided by the Argos system
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1 hour (before and after intervention)
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Argos study
- CE-SRLF 24-100 (Annen identifikator: SRLF)
Plan for individuelle deltakerdata (IPD)
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