Acute Respiratory Distress Syndrome (ARDS)ECMO-ECMOX2NCT04548739
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Cardiogenic Shock, run by Nantes University Hospital at 4 sites in 2 countries.
Trial summary
Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Cardiogenic Shock, Cardiac Arrest
- How many people
- 132 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 Oct 2020to 16 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients under the age of 18 years treated by ECMO
Who cannot join
- Lack of parental consent
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
CHU de Nantes
Nantes
AP-HP Trousseau Hospital
Paris, 75012
AP-HP Necker Hospital
Paris, 75015
About this study
Official title: Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2
Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.
Read the 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.
- Keywords
- ECMO, Cerebral autoregulation
- Medical subject headings
- Respiratory Distress Syndrome, Shock, Cardiogenic, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between CA metrics and neurological outcome
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.
Measured: 1 year
Secondary outcomes (2)
Analysis of the influence of PCO2 on CA
Association between PCO2 value (mmHg) and COX value
Measured: 1 year
Analysis of the influence of PCO2 on CA
Influence of ECMO settings on CA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start22 Oct 2020
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Giannina Gaslini, Pediatric Intensive Care Unit, Trousseau University Hospital, France, Pediatric Intensive Care Unit, Necker University Hospital, France, Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK
- Responsible party
- Sponsor
- Investigators
- Nicolas JORAM, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548739
- Sponsor's protocol ID
- RC20_0066
- Acronym
- ECMO-ECMOX2
- Status last verified
- Jan 2024
- First submitted
- 4 Jun 2020
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2
- ClinicalTrials.gov ID
- NCT04548739
- Acronym / sponsor ID
- ECMO-ECMOX2 / RC20_0066
- Keywords
- ECMO, Cerebral autoregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Istituto Giannina Gaslini, Pediatric Intensive Care Unit, Trousseau University Hospital, France, Pediatric Intensive Care Unit, Necker University Hospital, France, Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Patients under the age of 18 years treated by ECMO
Key exclusion criteria (1 listed)
- Lack of parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Analysis of the influence of PCO2 on CA
Time frame: 1 year
Analysis of the influence of PCO2 on CA
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas JORAM, MD principal investigator
Nantes University Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Cardiogenic Shock, run by Nantes University Hospital at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between CA metrics and neurological outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.