Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children

NCT05237232 | Recruiting

• 2 other identifiers: APHP2113062021-A01935-36
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis. This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).

Conditions

Extra Corporeal Membrane Oxygenation; Decanulated Alive

Keywords

Extra corporeal membrane oxygenation; Pediatric patients; Arterial circulation; Techniques of carotid decanulation; Circle of Willis; Magnetic Resonance Angiography

Outcome Measures

Primary Outcomes (1)

• Intracerebral arterial flows of patients treated with ECMO

  Comparison of intracerebral arterial flows according to the technique of reconstruction of the common carotid artery (reconstruction or ligation) after decanulation from data of MRA performed in weaned living patients off ECMO using computational fluid dynamic.

  1 month

Secondary Outcomes (3)

• Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO

  1 month

• Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy

  1 month

• Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy

  1 month

Study Arms (2)

Patients

Newborns, infants and children hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital, having been treated with jugulocarotid ECMO and weaned alive off ECMO.

Other: Modeling cerebral vascularization

Controls

Newborns treated for hypoxic-ischemic encephalopathy in the PICU of Trousseau Hospital.

Other: Magnetic Resonance Angiography (MRA) additional acquisition time; Other: Modeling cerebral vascularization

Interventions

Magnetic Resonance Angiography (MRA) additional acquisition time OTHER

Additional acquisition time, time of flight, during brain MRA of the care allowing to obtain the same quality of vascular anatomical visualization as the brain MRA with gadolinium contrast medium injection performed for the care of the patients treated with jugulocarotid ECMO.

Controls

Modeling cerebral vascularization OTHER

The modeling of cerebral vascularization from CRIMSON software (CaRdiovascular Integrated Modeling \& Simulation) requires several inputs: * The MRA images * The cardiac function curve * The cerebral blood flow * Measurement of systolic, diastolic and mean arterial blood pressure

Controls; Patients

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns, infants and children having been treated with jugulocarotid ECMO and weaned alive off ECMO and newborns treated for hypoxic-ischemic encephalopathy, hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital.

You may qualify if:

• For everyone :
• Information and non-opposition of holders of parental authority
• Newborn, infant and child \<20kg
• Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital
• Performing a Magnetic Resonance Angiography (MRA) as part of the treatment
• For patients treated with ECMO: study population
• Hemodynamic or respiratory failure
• Requiring the use of extracorporeal circulation with jugulo-carotid cannulation
• Weaned alive off Extra corporeal membrane oxygenation (ECMO)
• For patients with hypoxic-ischemic encephalopathy: control population
• hypoxic-ischemic encephalopathy diagnosed at birth

You may not qualify if:

• Contraindication to MRA
• Opposition of holders of parental authority

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Trousseau

Paris, 75012, France

RECRUITING

MeSH Terms

Interventions

tocilizumab

Study Officials

• Sabine Irtan, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Garance Martin, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Sabine Irtan, MD, PhD

CONTACT

1 71 73 87 98; sabine.irtan@aphp.fr

Hélène Morel

CONTACT

1 71 19 63 46; helene.morel@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 14, 2022
• Study Start: March 31, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)