Cardiogenic ShockECMOxygenNCT04934566
Venous Oxygen Saturation During ECMO Support
A study testing ECMO flow in people with Cardiogenic Shock, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- ECMO flow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 5 Aug 2021to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Absence of arterial line or central venous catheter
- Hemodynamic instability under ECMO support
- Malposition of ECMO venous canula
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille
Lille, NORD, 59000
About this study
Official title: Comprehensive and Comparative Analysis of Venous Oxygen Saturation During ECMO Support: a Pilot Study
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.
Read more
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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Being tested
- ECMO flow
- Keywords
- Refractory cardiogenic shock, Extracorporeal life support, venous oxygen saturation, physiology
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMO flowOther
Dynamic changes in ECMO flow and SvO2 measurement at the 3 different sites.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | patients receiving temporary veno-arterial assistance whose weaning, or transfer to a heart transplant, or to long-term assistance or discontinuation is envisaged. Receives: Other: ECMO flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 30 minutes of stability in the initial assistance condition (condition 1)
Secondary outcomes (5)
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
Measured: after 30 minutes of stability in the initial assistance condition (condition 1)
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
Measured: after 30 minutes of stability in the initial assistance condition (condition 1)
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)
Measured: More than 30 minutes of stability between each condition
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)
Measured: More than 30 minutes of stability between each condition
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
Measured: More than 30 minutes of stability between each condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start5 Aug 2021
- Primary completion24 Feb 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouhamed MOUSSA, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934566
- Sponsor's protocol ID
- 2019_58
- Other IDs
- 2020-A00505-34
- Acronym
- ECMOxygen
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive and Comparative Analysis of Venous Oxygen Saturation During ECMO Support: a Pilot Study
- ClinicalTrials.gov ID
- NCT04934566
- Acronym / sponsor ID
- ECMOxygen / 2019_58
- Conditions
- Cardiogenic Shock
- Keywords
- Refractory cardiogenic shock, Extracorporeal life support, venous oxygen saturation, physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: ECMO flowpatients receiving temporary veno-arterial assistance whose weaning, or transfer to a heart transplant, or to long-term assistance or discontinuation is envisaged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Absence of arterial line or central venous catheter
- Hemodynamic instability under ECMO support
- Malposition of ECMO venous canula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMO flowDynamic changes in ECMO flow and SvO2 measurement at the 3 different sites. | Other | patients |
Primary outcome
the intraclass correlation coefficient (ICC) between SECMOO2, and ScVO2 in the initial assist condition of 2-3 L/min (after 30 minutes of stability)
Time frame: after 30 minutes of stability in the initial assistance condition (condition 1)
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.
5 secondary outcomes
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
Time frame: after 30 minutes of stability in the initial assistance condition (condition 1)
ICC between ScVO2 and SVO2 measured after 30 minutes of stability
Time frame: after 30 minutes of stability in the initial assistance condition (condition 1)
Association between changes in SCVO2 and SECMOO2 measured at differents flow levels
Time frame: More than 30 minutes of stability between each condition
Association between changes in SVO2 and SECMOO2 measured at differents flow levels
Time frame: More than 30 minutes of stability between each condition
Association between each SVO2 derived variable with macrocirculatory, microcirculatory variables
Time frame: More than 30 minutes of stability between each condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mouhamed MOUSSA, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECMO flow in people with Cardiogenic Shock, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: after 30 minutes of stability in the initial assistance condition (condition 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.