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

Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure - a Posthoc Analysis of the ELSO Registry

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06899009
Enrollment
750
Registered
2025-03-27
Start date
2024-09-01
Completion date
2025-12-31
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Respiratory Failure (Pediatric Patients)

Keywords

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

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.

Detailed description

Rationale: Despite the growing use of ECMO in critically ill pediatric patients, uncertainties remain to what extent adjustments of ventilator settings after ECMO initiation are associated with mortality. Objectives: 1. To describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation; and 2. To explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure Hypothesis: 1. Ventilation intensity decreases following initiation of ECMO; and 2. A decrease in ventilation intensity is associated with lower hospital mortality in critically ill pediatric patients. Study design: This is a posthoc analysis of the ELSO registry. Study population: For this analysis, data will be obtained from the ELSO registry. All pediatric patients (aged ≥29 days to ≤18 years) receiving ECMO for a pulmonary indication between January 1, 2012, and December 31, 2022 will be included. Patients with missing ventilatory variables required to assess ventilation intensity and patients lost to follow up with respect to hospital mortality will be excluded.

Interventions

None listed

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
29 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Patients (aged ≥29 days to ≤18 years) receiving ECMO between January 1, 2012, and December 31, 2022, in an ELSO affiliated center; and 2. Requiring ECMO for a pulmonary indication.

Exclusion criteria

1. Patients with missing ventilatory variables required to assess ventilation intensity; 2. patients who were lost to follow up with respect to hospital mortality.

Design outcomes

Primary

MeasureTime frame
Hospital mortalityUp to 90 days of study or whatever comes first

Secondary

MeasureTime frame
Hospital length of stayUp to 90 days of study or whatever comes first
Duration of ECMO runUp to 90 days of study or whatever comes first
Duration of invasive ventilationUp to 90 days of study or whatever comes first

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026