Venous Oxygen Saturation During ECMO Support

NCT04934566 | Completed DMC

• 2 other identifiers: 2019_582020-A00505-34
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 1.to evaluate the concordance of the 3 variables describing oxygen saturation
2. 2.to analyse the primary objectives during prespecified and calibrated flow changes
3. 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. 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

Keywords

Refractory cardiogenic shock; Extracorporeal life support; venous oxygen saturation; physiology

Outcome Measures

Primary Outcomes (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)

  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.

  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

  after 30 minutes of stability in the initial assistance condition (condition 1)

• ICC between ScVO2 and SVO2 measured after 30 minutes of stability

  after 30 minutes of stability in the initial assistance condition (condition 1)

• Association between changes in SCVO2 and SECMOO2 measured at differents flow levels

  More than 30 minutes of stability between each condition

• Association between changes in SVO2 and SECMOO2 measured at differents flow levels

  More than 30 minutes of stability between each condition

• Association between each SVO2 derived variable with macrocirculatory, microcirculatory variables

  More than 30 minutes of stability between each condition

Study Arms (1)

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.

Other: ECMO flow

Interventions

ECMO flow OTHER

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

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Absence of arterial line or central venous catheter
• Hemodynamic instability under ECMO support
• Malposition of ECMO venous canula

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

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

Lille, NORD, 59000, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Mouhamed MOUSSA, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 22, 2021
• Study Start: August 5, 2021
• Primary Completion: February 24, 2025
• Study Completion: March 6, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)