NCT04934566Completed
Venous Oxygen Saturation During ECMO Support
Comprehensive and Comparative Analysis of Venous Oxygen Saturation During ECMO Support: a Pilot Study
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 10 Jun 2021
- Start date
- 5 Aug 2021
- Primary completion date
- 24 Feb 2025
- Lead sponsor
- University Hospital, Lille
- NCT number
- NCT04934566
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 5 Aug 2021 to the primary completion date, 24 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pregnancy
- Absence of arterial line or central venous catheter
- Hemodynamic instability under ECMO support
- Malposition of ECMO venous canula
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.