Clinical trial NCT03457090: Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.
Official title: Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation Complication
Keywords: neurologic complication, transcranial Doppler ultrasound
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient treated with Venoarterial Extracorporeal membrane oxygenation (ECMO) Realization of transcranial doppler (TCD) of the right and left middle cerebral artery in the first 48 hours of the setting up of the ECMO with joint realization of an Trans-thoracic echocardiography (TTE) then every 24 hours until the end of the using of the ECMO and the realization of TCD and TTE during the 24 hours after removal of the ECMO.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cerebral blood flow velocities evolution
timeFrame: 24 hours
measure: The correlation of Cerebral blood flow velocities with the variation of the cardiac output and ECMO flow.
timeFrame: 24 hours
Secondary outcomes:
measure: Relation between acute neurologic injury and variation of CBFV
timeFrame: 24 hours
measure: Modification of the CBFV detected by TCD after the withdrawal of the ECMO.
timeFrame: 24 hours
measure: Relation between the CBFV, the NIRS, the cardiac flow and the ECMO flow.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Fanny BOUNES, MD
role: PRINCIPAL_INVESTIGATOR
References: