NCT04934566: ECMOxygen

Venous Oxygen Saturation During ECMO Support

Completed NA Last updated 8 December 2025

What this trial tests

NA trial testing ECMO flow in Cardiogenic Shock in 48 participants. Completed in 6 March 2025.

Timeline

5 August 2021

Primary endpoint
24 February 2025

6 March 2025

Quick facts

Lead sponsor	University Hospital, Lille
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	48
Start date	5 August 2021
Primary completion	24 February 2025
Estimated completion	6 March 2025
Sites	1 location across France

Drugs / interventions tested

• ECMO flow

Conditions studied

• Cardiogenic Shock — all drugs for Cardiogenic Shock →

Sponsor

University Hospital, Lille

Who can join

18 and older, any sex, with Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.