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Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03457090
Acronym
ECMO-DTC
Enrollment
30
Registered
2018-03-07
Start date
2018-04-05
Completion date
2020-09-30
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

neurologic complication, transcranial Doppler ultrasound

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.

Interventions

OTHERExamination : 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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral blood flow velocities evolution24 hoursCerebral 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 hoursThe correlation with the variation of the cardiac output and ECMO flow.

Secondary

MeasureTime frameDescription
Relation between acute neurologic injury and variation of CBFV24 hoursRelation 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 hoursModification 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 hoursRelation between the CBFV (cerebral blood flow velocity), the Near Infrared Spectroscopy (NIRS), the cardiac flow and the ECMO flow.

Countries

France

Contacts

Primary ContactFanny BOUNES, MD
bounes.f@chu-toulouse.fr5 61 32 23 11
Backup ContactIsabelle OLIVIER, PhD
olivier.i@chu-toulouse.fr5 61 77 70 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026