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Venous Oxygen Saturation During ECMO Support (ECMOxygen)

Primary Purpose

Cardiogenic Shock

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ECMO flow
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiogenic Shock focused on measuring Refractory cardiogenic shock, Extracorporeal life support, venous oxygen saturation, physiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de LilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients

Arm Description

patients receiving temporary veno-arterial assistance whose weaning, or transfer to a heart transplant, or to long-term assistance or discontinuation is envisaged.

Outcomes

Primary Outcome Measures

the intraclass correlation coefficient (ICC) between SECMOO2, and ScVO2 in the initial assist condition of 2-3 L/min (after 30 minutes of stability)
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.

Secondary Outcome Measures

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
The intraclass correlation between SVO2 and SECMOO2 measured after 30 minutes of stability in
ICC between ScVO2 and SVO2 measured after 30 minutes of stability
Intracclass correlation between ScVO2 and SVO2 measured respectively in superior vena cava and pulmonary artery
Association between changes in SCVO2 and SECMOO2 measured at differents flow levels
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)
Association between changes in SVO2 and SECMOO2 measured at differents flow levels
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)
Association between each SVO2 derived variable with macrocirculatory, microcirculatory variables
Association between ScVO2, SVO2, SECMOO2 with VIS score , Peripheral Perfusion Index and capillary refill time and arterial lactate

Full Information

First Posted
June 10, 2021
Last Updated
May 3, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04934566
Brief Title
Venous Oxygen Saturation During ECMO Support
Acronym
ECMOxygen
Official Title
Comprehensive and Comparative Analysis of Venous Oxygen Saturation During ECMO Support: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 : to evaluate the concordance of the 3 variables describing oxygen saturation to analyse the primary objectives during prespecified and calibrated flow changes 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) 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.
Detailed Description
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 : to evaluate the concordance of the 3 variables describing oxygen saturation to analyse the primary objectives during prespecified and calibrated flow changes 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
Refractory cardiogenic shock, Extracorporeal life support, venous oxygen saturation, physiology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
patients receiving temporary veno-arterial assistance whose weaning, or transfer to a heart transplant, or to long-term assistance or discontinuation is envisaged.
Intervention Type
Other
Intervention Name(s)
ECMO flow
Intervention Description
Dynamic changes in ECMO flow and SvO2 measurement at the 3 different sites.
Primary Outcome Measure Information:
Title
the intraclass correlation coefficient (ICC) between SECMOO2, and ScVO2 in the initial assist condition of 2-3 L/min (after 30 minutes of stability)
Description
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.
Time Frame
after 30 minutes of stability in the initial assistance condition (condition 1)
Secondary Outcome Measure Information:
Title
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
Description
The intraclass correlation between SVO2 and SECMOO2 measured after 30 minutes of stability in
Time Frame
after 30 minutes of stability in the initial assistance condition (condition 1)
Title
ICC between ScVO2 and SVO2 measured after 30 minutes of stability
Description
Intracclass correlation between ScVO2 and SVO2 measured respectively in superior vena cava and pulmonary artery
Time Frame
after 30 minutes of stability in the initial assistance condition (condition 1)
Title
Association between changes in SCVO2 and SECMOO2 measured at differents flow levels
Description
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)
Time Frame
More than 30 minutes of stability between each condition
Title
Association between changes in SVO2 and SECMOO2 measured at differents flow levels
Description
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)
Time Frame
More than 30 minutes of stability between each condition
Title
Association between each SVO2 derived variable with macrocirculatory, microcirculatory variables
Description
Association between ScVO2, SVO2, SECMOO2 with VIS score , Peripheral Perfusion Index and capillary refill time and arterial lactate
Time Frame
More than 30 minutes of stability between each condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mouhamed MOUSSA, MD
Phone
0320445962
Ext
+33
Email
mouhamed.moussa@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mouhamed MOUSSA, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mouhamed D Moussa, MD
Phone
=33659248780
Email
mouhamed.moussa@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Julien Tabareau
Phone
0320445962
Email
julien.tabareau@chru-lille.fr

12. IPD Sharing Statement

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Venous Oxygen Saturation During ECMO Support

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