Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure

NCT06899009 | Active Not Recruiting

• 1 other identifier: Ped.ECMO.1
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation and to explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure, using the 'Extracorporeal Life Support Organization' (ELSO) registry.

Conditions

Critical Illness; Respiratory Failure (Pediatric Patients)

Keywords

Ventilation practice; Critically ill children; Mechanical ventilation; Extracorporeal membrane oxygenation; Extracorporeal lief support

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  Up to 90 days of study or whatever comes first

Secondary Outcomes (3)

• Hospital length of stay

  Up to 90 days of study or whatever comes first

• Duration of ECMO run

  Up to 90 days of study or whatever comes first

• Duration of invasive ventilation

  Up to 90 days of study or whatever comes first

Study Arms (1)

Children with respiratory failure on ECMO

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Critically ill pediatric patients receiving ECMO for pulmonary indications

You may qualify if:

• Patients (aged ≥29 days to ≤18 years) receiving ECMO between January 1, 2012, and December 31, 2022, in an ELSO affiliated center; and
• Requiring ECMO for a pulmonary indication.

You may not qualify if:

• Patients with missing ventilatory variables required to assess ventilation intensity;
• patients who were lost to follow up with respect to hospital mortality.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Martin CJ Kneyber, MD PhD FCCM

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Marcus J Schultz, MD PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Frederique Paulus, RN PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)