Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.

Not Applicable

• Conditions: Extracorporeal Membrane Oxygenation Complication

• Registration Number: NCT03457090
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-07
• Status Verified: 2018-04
• Study Start: 2018-04-05
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow velocities evolution	24 hours	Cerebral blood flow velocities evolution over the time
The correlation of Cerebral blood flow velocities with the variation of the cardiac output and ECMO flow.	24 hours	The correlation with the variation of the cardiac output and ECMO flow.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, France