Venous Oxygen Saturation During ECMO Support

NCT ID: NCT04934566

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2025-03-06

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.

Conditions

Cardiogenic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients

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

Group Type: EXPERIMENTAL

ECMO flow

Intervention Type: OTHER

Dynamic changes in ECMO flow and SvO2 measurement at the 3 different sites.

Interventions

ECMO flow

Dynamic changes in ECMO flow and SvO2 measurement at the 3 different sites.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mouhamed MOUSSA, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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

Lille, NORD, France

Countries

France

Other Identifiers

2020-A00505-34

Identifier Type: OTHER

Identifier Source: secondary_id

2019_58

Identifier Type: -

Identifier Source: org_study_id