Extracorporeal Membrane Oxygenation ComplicationECMOX1NCT04282525
Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)
An observational study of Extracorporeal Membrane Oxygenation Complication, run by Nantes University Hospital at 1 site in France.
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. Our first objective is to investigate the feasibility of CA continuous monitoring during ECMO treatment. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- ECMO for hemodynamic or respiratory indication
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 1 Jun 2019
- 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: Patients from 0 to 18 years treated by ECMO
Who may be able to join
- Patients 18 years treated by ECMO
Who cannot join
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
About this study
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. Our first objective is to investigate the feasibility of CA continuous monitoring during ECMO treatment. The second objective is to analyze the relationship between CA impairment and neurological outcome.
Read the detailed description
Patients : All children treated by ECMO in the PICU of the Universitary hospital of Nantes, France and of IRCCS Giannina Gaslini Institute, Genoa, Italy
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.
- Being tested
- ECMO for hemodynamic or respiratory indication
- Keywords
- ECMO, cerebral autoregulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMO for hemodynamic or respiratory indicationOther
ECMO for hemodynamic or respiratory indication
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of continuous cerebral autoregulation monitoring
Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation
Measured: 12 hours before Extra-Corporeal Membrane Oxygenation
Feasibility of continuous cerebral autoregulation monitoring
Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation
Measured: During Extra-Corporeal Membrane Oxygenation
Feasibility of continuous cerebral autoregulation monitoring
Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation
Measured: 12 hours after Extra-Corporeal Membrane Oxygenation
Secondary outcomes (1)
Correlation between cerebral autoregulation metrics and neurological outcome
Correlation between the percentage of time spent in critical region of cerebral autoregulation and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not
Measured: 12 hours after Extra-Corporeal Membrane Oxygenation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Giannina Gaslini, University of Cambridge
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282525
- Sponsor's protocol ID
- ECMOX1
- Acronym
- ECMOX1
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Impact of Arterial Carbon Dioxide and Oxygen Content on Cerebral Autoregulation Monitoring Among Children Supported by ECMO. Neurocrit Care. 2021 Oct;35(2):480-490. doi: 10.1007/s12028-021-01201-8. Epub 2021 Mar 9.
PubMed 33686559Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Continuous Monitoring of Cerebral Autoregulation in Children Supported by Extracorporeal Membrane Oxygenation: A Pilot Study. Neurocrit Care. 2021 Jun;34(3):935-945. doi: 10.1007/s12028-020-01111-1. Epub 2020 Oct 8.
PubMed 33029743
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)
- ClinicalTrials.gov ID
- NCT04282525
- Acronym / sponsor ID
- ECMOX1 / ECMOX1
- Keywords
- ECMO, cerebral autoregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Istituto Giannina Gaslini, University of Cambridge
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 24 Feb 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. Our first objective is to investigate the feasibility of CA continuous monitoring during ECMO treatment. The second objective is to analyze the relationship between CA impairment and neurological outcome.
Detailed description
Patients : All children treated by ECMO in the PICU of the Universitary hospital of Nantes, France and of IRCCS Giannina Gaslini Institute, Genoa, Italy
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
- Patients from 0 to 18 years treated by ECMO
Key inclusion criteria (1 listed)
- Patients 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMO for hemodynamic or respiratory indicationECMO for hemodynamic or respiratory indication | Other | – |
Primary outcome
Feasibility of continuous cerebral autoregulation monitoring
Time frame: 12 hours before Extra-Corporeal Membrane Oxygenation
Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation
Feasibility of continuous cerebral autoregulation monitoring
Time frame: During Extra-Corporeal Membrane Oxygenation
Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation
Feasibility of continuous cerebral autoregulation monitoring
Time frame: 12 hours after Extra-Corporeal Membrane Oxygenation
Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation
1 secondary outcome
Correlation between cerebral autoregulation metrics and neurological outcome
Time frame: 12 hours after Extra-Corporeal Membrane Oxygenation
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 24 Feb 2020.
- Derived from this study: PubMed 33686559Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Impact of Arterial Carbon Dioxide and Oxygen Content on Cerebral Autoregulation Monitoring Among Children Supported by ECMO. Neurocrit Care. 2021 Oct;35(2):480-490. doi: 10.1007/s12028-021-01201-8. Epub 2021 Mar 9.
- Derived from this study: PubMed 33029743Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Continuous Monitoring of Cerebral Autoregulation in Children Supported by Extracorporeal Membrane Oxygenation: A Pilot Study. Neurocrit Care. 2021 Jun;34(3):935-945. doi: 10.1007/s12028-020-01111-1. Epub 2020 Oct 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation Complication, run by Nantes University Hospital at 1 site in France.
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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Feasibility of continuous cerebral autoregulation monitoring (time frame: 12 hours before Extra-Corporeal Membrane Oxygenation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282525, which also lists 2 linked publications.
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 24 Feb 2020.