Assessment of Cardiac Output in Patients With ARDS Implanted With Venous-venous ECMO.

NCT05164484 | Unknown

• 2 other identifiers: APHP2105622020-A03287-32
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with severe acute respiratory distress syndrome, extracorporeal membrane oxygenation (ECMO), which also as known as extracorporeal life support, may be used. This technique helps the lungs by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas exchange. The ECMO device includes a pump for draining and returning blood at a certain blood flow rate (ECMO blood flow). An ECMO rate that is adapted to the patient's cardiac output (CO) is essential for effective oxygenation for patients. The objective for clinicians is an ECMO blood flow to cardiac output ≥40%, which can go up to 100% as needed. In addition to the expected benefit in the management of the patient with ARDS, measuring CO is, therefore, all the more important in patients requiring ECMO. Monitoring CO in a patient with ECMO is not only for determining the minimum ECMO blood flow rate but also for optimizing the functioning of the ECMO. However, the validity of techniques for measuring CO in patients with ECMO has been poorly studied. The reliability of the CO measurement by transpulmonary thermodilution is questioned since the extracorporeal circulation may influence the pathway of cold indicator injected into the patients' circulation and the thermodilution curve measured from the femoral arterial is thereby modified.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Venovenous Extracorporeal Membrane Oxygenation; Pulmonary Thermodilution; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• The measurements of CO by transpulmonary thermodilution compared to CO measured by echocardiography

  Standard measurements by injection of three cold bolus in the venous circulation for transpulmonary thermodilution and standard echocardiography procedures.

  The first week during patient is under ECMO assistance

Secondary Outcomes (5)

• The CO measurements by pulse contour analyse at different ECMO blood flow/CO ratio.

  The first week during patient is under ECMO assistance

• The changes of transpulmonary thermodilution parameter :GEDVI measured at different ECMO blood flow/CO ratio.

  The first week during patient is under ECMO assistance

• The changes of transpulmonary thermodilution parameter : CFI measured at different ECMO blood flow/CO ratio.

  The first week during patient is under ECMO assistance

• The changes of transpulmonary thermodilution parameters : EVLWI measured at different ECMO blood flow/CO ratio.

  The first week during patient is under ECMO assistance

• The changes of transpulmonary thermodilution parameter : PVPI (Pulmonary Vascular Permeability Index) measured at different ECMO blood flow/CO ratio.

  The first week during patient is under ECMO assistance

Study Arms (1)

Transpulmonary thermodilution in patients implanted with VV-ECMO during standard care for ARDS

OTHER

Standard of care procedure for patient with severe ARDS

Device: Transpulmonary thermodilution

Interventions

Transpulmonary thermodilution DEVICE

Through the analysis of the thermodilution curve recorded at the tip of an arterial catheter after the injection of a cold bolus in the venous circulation, transpulmonary thermodilution intermittently measures cardiac output.

Transpulmonary thermodilution in patients implanted with VV-ECMO during standard care for ARDS

Eligibility Criteria

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

You may qualify if:

• ≥18yrs.
• With acute respiratory distress syndrome.
• Monitored by transpulmonary thermodilution device.
• Implanted by VV-ECMO.
• Affiliated to the French Health Insurance

You may not qualify if:

• Pregnancy
• Patient placed under judicial protection
• Patient on state medical aid (AME, Aide Medicale d'Etat)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de médecine intensive-réanimation de l'Hôpital Bicêtre

Le Kremlin-Bicêtre, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Christopher LAI, M.D.

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher LAI, M.D.

CONTACT

33 (0)1 45 21 26 71; christopher.lai@aphp.fr

Xavier MONNET, M.D., Ph.D.

CONTACT

33 (0)6 60 86 26 69; xavier.monnet@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: December 20, 2021
• Study Start: January 19, 2021
• Primary Completion: December 15, 2024
• Study Completion: January 15, 2025
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

FR (1)