Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler. (ECMO-DTC)

Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler

To determine how venoarterial extracorporeal membrane oxygenation (ECMO) affects cerebral blood flow velocity (CBFV) measured by transcranial doppler (TCD), to determine whether specific changes in cerebral blood flow velocity may be associated with neurologic injury and to determine modifications of CBFV after withdrawal of ECMO.

Study Overview

• Status: Unknown
• Conditions: Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Other: Examination : a TCD and Trans-Thoracic Echocardiography

Detailed Description

Venoarterial Extracorporeal membrane oxygenation (ECMO) is used in adult with refractory cardiac failure as a life-saving measure. Adults treated with ECMO survived to hospital discharge in 21,8% to 65,4% of cases. Neurologic complications such as intracranial hemorrhage, anoxia and ischemia are major causes of death and long-term disability in ECMO patients (7% to 14%). Current neurological monitoring techniques are insufficient to predict which critically ill patient receiving ECMO therapy will suffer from neurologic injury. Even after a clinical suspicion of neurologic injury, diagnosis can be difficult. TCD is commonly used to monitor the CBFV of traumatic brain injury. There are no reports that evaluate CBFV of patients requiring ECMO therapy. Patient will have to do both echocardiography and TCD to evaluate cardiac output and CBFV. We will repeat these dopplers every 24 hours until ECMO withdrawal and one day after explantation.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fanny BOUNES, MD; Phone Number: 33 5 61 32 23 11; Email: bounes.f@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital Toulouse
    • Contact: Fanny BOUNES, MD; Phone Number: 33 5 61 32 23 11; Email: bounes.f@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patient who receiving ECMO therapy

Exclusion Criteria:

• cervico-encephalic vasculopathy
• lacked an acoustic window allowing for adequate TCD examination
• stroke in medical past.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient treated with ECMO; Patient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE)

Other: Examination : a TCD and Trans-Thoracic Echocardiography; Examination that involves the completion of a TCD and an TTE (Trans-Thoracic Echocardiography) : To reports clinical parameters at the time of the examination : ECG data: sinus rhythm, atrial or ventricular arrhythmia, state of consciousness, heart rate, O2 saturation; To review of pharmacological parameters at the time of the examination : presence of sedation; presence, type and dose of catecholamines.; To collect biological data from the day of the examination : Partial Pressure of O2, PaCO2 (partial pressure) and hematocrit; To collect possible additional examinations : brain scan, EEG. These are non-invasive exams that do not require patient displacement. Only the samples taken by the medical team as part of the treatment will be analyzed.; Other Names: Examination that involves a TCD and an TTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral blood flow velocities evolution	Cerebral blood flow velocities evolution over the time	24 hours
The correlation of Cerebral blood flow velocities with the variation of the cardiac output and ECMO flow.	The correlation with the variation of the cardiac output and ECMO flow.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relation between acute neurologic injury and variation of CBFV	Relation between acute neurologic injury and variation of CBFV detected by TCD.	24 hours
Modification of the CBFV detected by TCD after the withdrawal of the ECMO.	Modification of the cerebral blood flow velocity (CBFV) detected by TCD after the withdrawal of the ECMO.	24 hours
Relation between the CBFV, the NIRS, the cardiac flow and the ECMO flow.	Relation between the CBFV (cerebral blood flow velocity), the Near Infrared Spectroscopy (NIRS), the cardiac flow and the ECMO flow.	24 hours

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Fanny BOUNES, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: neurologic complication, transcranial Doppler ultrasound
• Other Study ID Numbers: RC31/18/0042; 2018-A00320-55 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No