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Venous Oxygen Saturation During ECMO Support (ECMOxygen)

3. maj 2022 opdateret af: University Hospital, Lille

Comprehensive and Comparative Analysis of Venous Oxygen Saturation During ECMO Support: a Pilot Study

Extracorporeal veno-arterial membrane oxygenation" (ECMO-VA), are used to manage refractory cardiogenic shocks by replacing the failed "heart-lung" block. The Extracorporeal Life Support Organisation guidelines considers that the effectiveness of these techniques must be evaluated on the adequacy of tissue perfusion biomarker, of which is O2 saturation of venous blood found in the pulmonary artery using a Swan-Ganz catheter (SVO2) or in the superior vena cava/right atrium using a central venous catheter (ScVO2). During ECMO support, it can be also measured directly in the venous ECMO cannula (SmVO2).

However, due to the difference in tips locations of the venous cannula of ECMO-VA, the central venous catheter and the Swan-Ganz catheter, and rheological issues, the SmVO2, SVO2 and ScVO2 values obtained may be different.

Further we hypothesised that the level of admission flow may also affect the correlation between these different variables.

The aim of this experimental study is to investigate the concordance of the saturation of venous blood collected from these 3 measurement sites.

The primary objectives is to compare the concordance of ScVO2 and the SmVO2, the two more easily and systematically available variables

The secondary objectives were :

  1. to evaluate the concordance of the 3 variables describing oxygen saturation
  2. to analyse the primary objectives during prespecified and calibrated flow changes
  3. analyse the association between these 3 variables with prognosis variables (Perfusion index, lactatemia, CO2 veno-arterial differences, SOFA score, SAPS II, successful weaning from the ECMO)
  4. analyse in an ancilary study the concordance between SmVO2 measured using blood sample and the value obtained using a continuous monitoring of SVO2 through the circuit.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Extracorporeal veno-arterial membrane oxygenation" (ECMO-VA), are used to manage refractory cardiogenic shocks by replacing the failed "heart-lung" block. The Extracorporeal Life Support Organisation guidelines considers that the effectiveness of these techniques must be evaluated on the adequacy of tissue perfusion biomarker, of which is O2 saturation of venous blood found in the pulmonary artery using a Swan-Ganz catheter (SVO2) or in the superior vena cava/right atrium using a central venous catheter (ScVO2). During ECMO support, it can be also measured directly in the venous ECMO cannula (SmVO2).

However, due to the difference in tips locations of the venous cannula of ECMO-VA, the central venous catheter and the Swan-Ganz catheter, and rheological issues, the SmVO2, SVO2 and ScVO2 values obtained may be different.

Further we hypothesised that the level of admission flow may also affect the correlation between these different variables.

The aim of this experimental study is to investigate the concordance of the saturation of venous blood collected from these 3 measurement sites.

The primary objectives is to compare the concordance of ScVO2 and the SmVO2, the two more easily and systematically available variables

The secondary objectives were :

  1. to evaluate the concordance of the 3 variables describing oxygen saturation
  2. to analyse the primary objectives during prespecified and calibrated flow changes
  3. analyse the association between these 3 variables with prognosis variables (Perfusion index, lactatemia, CO2 veno-arterial differences, SOFA score, SAPS II, successful weaning from the ECMO)
  4. analyse in an ancilary study the concordance between SmVO2 measured using blood sample and the value obtained using a continuous monitoring of SVO2 through the circuit.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
    • Nord
      • Lille, Nord, Frankrig, 59000
        • Rekruttering
        • Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Weight >50 kg
  • Veno-arterial ECMO with impending removal (for recovery, heart transplantation or LVAD/BIVAD implantation or support futility)
  • Venous catheter tip positioned in the superior vena cava or right heart
  • Arterial line for blood pressure monitoring
  • Given informed consent

Exclusion Criteria:

  • Pregnancy
  • Absence of arterial line or central venous catheter
  • Hemodynamic instability under ECMO support
  • Malposition of ECMO venous canula

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: patients
patients receiving temporary veno-arterial assistance whose weaning, or transfer to a heart transplant, or to long-term assistance or discontinuation is envisaged.
Andet: ECMO flow
Dynamic changes in ECMO flow and SvO2 measurement at the 3 different sites.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the intraclass correlation coefficient (ICC) between SECMOO2, and ScVO2 in the initial assist condition of 2-3 L/min (after 30 minutes of stability)
Tidsramme: after 30 minutes of stability in the initial assistance condition (condition 1)
the intraclass correlation coefficient (ICC) between SECMOO2, and ScVO2 in the initial assist condition of 2-3 L/min (after 30 minutes of stability). Due to the importance of patient position, measurements will be standardized in supine position or with head of bed inclination less than 30% SVO2 measured on ECMO circuit and in patient's superior vena cava.
after 30 minutes of stability in the initial assistance condition (condition 1)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICC between SVO2 and SECMOO2 measured after 30 minutes of stability in the initial assist condition (2-3 L/min), in patients with a Swan-Ganz catheter
Tidsramme: after 30 minutes of stability in the initial assistance condition (condition 1)
The intraclass correlation between SVO2 and SECMOO2 measured after 30 minutes of stability in
after 30 minutes of stability in the initial assistance condition (condition 1)
ICC between ScVO2 and SVO2 measured after 30 minutes of stability
Tidsramme: after 30 minutes of stability in the initial assistance condition (condition 1)
Intracclass correlation between ScVO2 and SVO2 measured respectively in superior vena cava and pulmonary artery
after 30 minutes of stability in the initial assistance condition (condition 1)
Association between changes in SCVO2 and SECMOO2 measured at differents flow levels
Tidsramme: More than 30 minutes of stability between each condition
Changes in ScVO2 and SECMOO2 are measured at 4 differents conditions from Baseline (Condition 1). Those condictions will consist in 2 successive increaments in ECMO flow of 1000 ml each (Condition 2 and condition 3), followed by a return to the baseline ECMO Flow ( Condition 4)
More than 30 minutes of stability between each condition
Association between changes in SVO2 and SECMOO2 measured at differents flow levels
Tidsramme: More than 30 minutes of stability between each condition
Changes in ScVO2 and SECMOO2 are measured at 4 differents conditions from Baseline (Condition 1). Those condictions will consist in 2 successive increaments in ECMO flow of 1000 ml each (Condition 2 and condition 3), followed by a return to the baseline ECMO Flow ( Condition 4)
More than 30 minutes of stability between each condition
Association between each SVO2 derived variable with macrocirculatory, microcirculatory variables
Tidsramme: More than 30 minutes of stability between each condition
Association between ScVO2, SVO2, SECMOO2 with VIS score , Peripheral Perfusion Index and capillary refill time and arterial lactate
More than 30 minutes of stability between each condition

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Lille

Efterforskere

  • Ledende efterforsker: Mouhamed MOUSSA, MD, University Hospital, Lille

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. august 2021

Primær færdiggørelse (Forventet)

15. juni 2023

Studieafslutning (Forventet)

15. juni 2023

Datoer for studieregistrering

Først indsendt

10. juni 2021

Først indsendt, der opfyldte QC-kriterier

21. juni 2021

Først opslået (Faktiske)

22. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019_58
  • 2020-A00505-34 (Anden identifikator: ID-RCB number,ANSM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Kardiogent stød

Kliniske forsøg med ECMO flow

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