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

University Medical Center Groningen (UMCG)

Status: Active, not recruiting

Conditions: Respiratory Failure (Pediatric Patients); Critical Illness

Study type: Observational

Funder types: Other

Identifiers

NCT06899009

Ped.ECMO.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 patients

Sex: All

Ages: 29 days to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

750 participants in 1 patient group

Children with respiratory failure on ECMO