Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.

NCT ID: NCT03457090

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2020-09-30

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.

Conditions

Extracorporeal Membrane Oxygenation Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient treated with ECMO

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

Group Type: EXPERIMENTAL

Examination : a TCD and Trans-Thoracic Echocardiography

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Examination that involves a TCD and an TTE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fanny BOUNES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fanny BOUNES, MD

Role: CONTACT

bounes.f@chu-toulouse.fr

5 61 32 23 11 ext. 33

Isabelle OLIVIER, PhD

Role: CONTACT

olivier.i@chu-toulouse.fr

5 61 77 70 51 ext. 33

Facility Contacts

Fanny BOUNES, MD

Role: primary

bounes.f@chu-toulouse.fr

5 61 32 23 11 ext. 33

Isabelle Olivier, PhD

Role: backup

olivier.i@chu-toulouse.fr

5 61 77 70 51 ext. 33

Other Identifiers

2018-A00320-55

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0042

Identifier Type: -

Identifier Source: org_study_id