Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

NCT04548739 | Completed

• 1 other identifier: RC20_0066
• Study Type: observational
• Target: 132
• Locations: 2 countries
• Sites: 4

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. 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.

Conditions

Acute Respiratory Distress Syndrome (ARDS); Cardiogenic Shock; Cardiac Arrest

Keywords

ECMO; Cerebral autoregulation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Analysis of the influence of PCO2 on CA

  1 year

• Analysis of the influence of PCO2 on CA

  1 year

Eligibility Criteria

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

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.

You may qualify if:

• Patients under the age of 18 years treated by ECMO

You may not qualify if:

• Lack of parental consent

Sponsors & Collaborators

• Nantes University Hospital: lead
• Istituto Giannina Gaslini: collaborator
• Pediatric Intensive Care Unit, Trousseau University Hospital, France: collaborator
• Pediatric Intensive Care Unit, Necker University Hospital, France: collaborator
• Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK: collaborator

Study Sites (4)

CHU de Nantes

Nantes, France

Location

AP-HP Trousseau Hospital

Paris, 75012, France

Location

AP-HP Necker Hospital

Paris, 75015, France

Location

Giannina Gaslini Institute (IRCCS)

Genova, 16148, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Shock, Cardiogenic; Heart Arrest

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Nicolas JORAM, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: September 14, 2020
• Study Start: October 22, 2020
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

FR (3); IT (1)