Clinical trial NCT06899009: Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure
Official title: Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure - a Posthoc Analysis of the ELSO Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Respiratory Failure (Pediatric Patients)
Keywords: Ventilation practice
Critically ill children
Mechanical ventilation
Extracorporeal membrane oxygenation
Extracorporeal lief support
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2025-03-27
Enrollment: 750
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill pediatric patients receiving ECMO for pulmonary indications

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital mortality
timeFrame: Up to 90 days of study or whatever comes first
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Up to 90 days of study or whatever comes first
measure: Duration of ECMO run
timeFrame: Up to 90 days of study or whatever comes first
measure: Duration of invasive ventilation
timeFrame: Up to 90 days of study or whatever comes first
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Martin CJ Kneyber, MD PhD FCCM
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marcus J Schultz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Frederique Paulus, RN PhD
role: PRINCIPAL_INVESTIGATOR
References: