Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.

NCT03457090 | Unknown

• 2 other identifiers: RC31/18/00422018-A00320-55
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

neurologic complication, transcranial Doppler ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Relation between acute neurologic injury and variation of CBFV

  24 hours

• Modification of the 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.

  24 hours

Study Arms (1)

Patient treated with ECMO

EXPERIMENTAL

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

Other: Examination : a TCD and Trans-Thoracic Echocardiography

Interventions

Examination : a TCD and Trans-Thoracic Echocardiography 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.

Also known as: Examination that involves a TCD and an TTE

Patient treated with ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patient who receiving ECMO therapy

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

Study Officials

• Fanny BOUNES, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny BOUNES, MD

CONTACT

5 61 32 23 11; bounes.f@chu-toulouse.fr

Isabelle OLIVIER, PhD

CONTACT

5 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 7, 2018
• Study Start: April 5, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

FR (1)