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Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler. (ECMO-DTC)

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ClinicalTrials.gov Identifier: NCT03457090
Recruitment Status : Unknown
Verified April 2018 by University Hospital, Toulouse.
Recruitment status was:  Recruiting
First Posted : March 7, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE March 7, 2018
Last Update Posted Date April 18, 2018
Actual Study Start Date  ICMJE April 5, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Cerebral blood flow velocities evolution [ Time Frame: 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. [ Time Frame: 24 hours ]
    The correlation with the variation of the cardiac output and ECMO flow.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Relation between acute neurologic injury and variation of CBFV [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 24 hours ]
    Relation between the CBFV (cerebral blood flow velocity), the Near Infrared Spectroscopy (NIRS), the cardiac flow and the ECMO flow.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extracorporeal Membrane Oxygenation Evaluated by Transcranial Doppler.
Official Title  ICMJE Extracorporeal Membrane Oxygenation and Cerebral Blood Flow Velocity Evaluated by Transcranial Doppler
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Extracorporeal Membrane Oxygenation Complication
Intervention  ICMJE Other: 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.
Other Name: Examination that involves a TCD and an TTE
Study Arms  ICMJE Experimental: Patient treated with ECMO
Patient treated with ECMO will have Examination : a TCD and Trans-Thoracic Echocardiography (TTE)
Intervention: Other: Examination : a TCD and Trans-Thoracic Echocardiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 5, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03457090
Other Study ID Numbers  ICMJE RC31/18/0042
2018-A00320-55 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fanny BOUNES, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP