Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

NCT04282525 | Completed

• 1 other identifier: ECMOX1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. The second objective is to analyze the relationship between CA impairment and neurological outcome.

Conditions

Extracorporeal Membrane Oxygenation Complication

Keywords

ECMO; cerebral autoregulation

Outcome Measures

Primary Outcomes (3)

• Feasibility of continuous cerebral autoregulation monitoring

  Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation

  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

  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

  12 hours after Extra-Corporeal Membrane Oxygenation

Secondary Outcomes (1)

• Correlation between cerebral autoregulation metrics and neurological outcome

  12 hours after Extra-Corporeal Membrane Oxygenation

Interventions

ECMO for hemodynamic or respiratory indication OTHER

ECMO for hemodynamic or respiratory indication

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients from 0 to 18 years treated by ECMO

You may qualify if:

• Patients 18 years treated by ECMO

You may not qualify if:

• Lack of parental consent

Sponsors & Collaborators

• Nantes University Hospital: lead
• Istituto Giannina Gaslini: collaborator
• University of Cambridge: collaborator

Study Sites (1)

University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Related Publications (2)

• 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.

  PMID: 33686559 DERIVED

• Joram 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.

  PMID: 33029743 DERIVED

MeSH Terms

Interventions

Extracorporeal Membrane Oxygenation; Hemodynamics

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: June 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)