Clinical trial NCT04934566: Venous Oxygen Saturation During ECMO Support
Official title: Comprehensive and Comparative Analysis of Venous Oxygen Saturation During ECMO Support: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Refractory cardiogenic shock
Extracorporeal life support
venous oxygen saturation
physiology
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 :

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.

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 :

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.

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

Primary outcomes:
measure: the intraclass correlation coefficient (ICC) between SECMOO2, and ScVO2 in the initial assist condition of 2-3 L/min (after 30 minutes of stability)
timeFrame: after 30 minutes of stability in the initial assistance condition (condition 1)
Secondary outcomes:
measure: 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
timeFrame: after 30 minutes of stability in the initial assistance condition (condition 1)
measure: ICC between ScVO2 and SVO2 measured after 30 minutes of stability
timeFrame: after 30 minutes of stability in the initial assistance condition (condition 1)
measure: Association between changes in SCVO2 and SECMOO2 measured at differents flow levels
timeFrame: More than 30 minutes of stability between each condition
measure: Association between changes in SVO2 and SECMOO2 measured at differents flow levels
timeFrame: More than 30 minutes of stability between each condition
measure: Association between each SVO2 derived variable with macrocirculatory, microcirculatory variables
timeFrame: More than 30 minutes of stability between each condition
Other outcomes:
Locations:
city: Lille
country: France
facility: Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
state: Nord
Study officials:
affiliation: University Hospital, Lille
name: Mouhamed MOUSSA, MD
role: PRINCIPAL_INVESTIGATOR
References: