- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04548739
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) (ECMO-ECMOX2)
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2
Study Overview
Status
Detailed Description
Patients : All children treated by ECMO in the 4 PICUs involved in the study
Measurements : A correlation coefficient between the variations of regional cerebral oxygen saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx), ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx > 0.3 is considered as critical. Neurological outcome is assessed by the onset of an acute neurologic event (ANE) during the ECMO run.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Nicolas JORAM, MD
- Phone Number: 02 40 08 76 74
- Email: nicolas.joram@chu-nantes.fr
Study Contact Backup
- Name: Annick COULON
- Phone Number: 02 53 48 28 35
- Email: bp-prom-regl@chu-nantes.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
100 children admitted to the Pediatric Intensive Care Unit (PICU) of Nantes (France), Trousseau (Paris, France), Necker (Paris, France) or Genoa (Italy) and supported by ECMO for hemodynamic or respiratory indication or during cardiac arrest resuscitation will be included in the study.
As ECMO is an emergency procedure, emergency inclusions may be needed. Other observational study may be conducted in parallel in this population.
Description
Inclusion Criteria :
- Patients under the age of 18 years treated by ECMO
Exclusion Criteria :
- Lack of parental consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between CA metrics and neurological outcome
Time Frame: 1 year
|
Association between the percentage of time spent in critical region of CA and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of the influence of PCO2 on CA
Time Frame: 1 year
|
Association between PCO2 value (mmHg) and COX value
|
1 year
|
Analysis of the influence of PCO2 on CA
Time Frame: 1 year
|
Influence of ECMO settings on CA
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicolas JORAM, MD, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Shock
- Myocardial Infarction
- Infarction
- Lung Injury
- Infant, Premature, Diseases
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Shock, Cardiogenic
Other Study ID Numbers
- RC20_0066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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