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

Active, not recruiting

• Conditions: Critical Illness; Respiratory Failure (Pediatric Patients)

• Registration Number: NCT06899009
• Lead Sponsor: University Medical Center Groningen

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.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital mortality	Up to 90 days of study or whatever comes first

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands