NCT06899009

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
• Phase: —
• Study type: Observational
• Enrollment: 750 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 29 Days – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Respiratory Failure (Pediatric Patients)

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-03-01
• Completion: 2025-12-31
• First posted: 2025-03-27
• Last updated: 2025-03-27

Locations

1 site across 1 country: Netherlands