- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Christopher Lai, MD, PhD
- Numero di telefono: 12633816521
- Email: christopher.lai@aphp.fr
Luoghi di studio
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Le Kremlin-Bicêtre, Francia
- Reclutamento
- Bicêtre Hospital
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Contatto:
- Christopher Lai
- Numero di telefono: 2633816521
- Email: christopher.lai@aphp.fr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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.
Lasso di tempo: 1 hour (before and after intervention)
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1 hour (before and after intervention)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Accuracy of the Argos system
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Argos study
- CE-SRLF 24-100 (Altro identificatore: SRLF)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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King's College Hospital NHS TrustUniversity Hospital BirminghamCompletatoShock emorragico traumaticoRegno Unito
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University of Texas Southwestern Medical CenterUniversity of Washington; Resuscitation Outcomes ConsortiumCompletato
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Artcline GmbHReclutamentoSepsi | Shock settico | Immunoparalisi nello Shock SetticoGermania
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Ramathibodi HospitalSconosciutoShock settico | Shock refrattarioTailandia
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German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnSconosciutoSepsi grave con shock settico | Sepsi grave senza shock setticoGermania
Prove cliniche su Fluid bolus
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Rabin Medical CenterCompletatoDiabete di tipo 1Israele
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PowerVisionCompletatoAfachiaSud Africa, Germania
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Nanogen, Inc.Centers for Disease Control and PreventionSospeso
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PowerVisionCompletatoAfachiaUngheria, Sud Africa
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Bursa City HospitalNon ancora reclutamentoChirurgia Pediatrica | Digiuno preoperatorio | Protocollo ERAS (Recupero migliorato dopo l'intervento chirurgico).Turchia (Türkiye)
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PowerVisionCompletato
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PowerVisionCompletatoCatarattaSud Africa
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