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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Illness; Respiratory Failure (Pediatric Patients)

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 Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill pediatric patients receiving ECMO for pulmonary indications

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children with respiratory failure on ECMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital mortality	Up to 90 days of study or whatever comes first

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Martin CJ Kneyber, MD PhD FCCM, University Medical Center Groningen; Principal Investigator: Marcus J Schultz, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Principal Investigator: Frederique Paulus, RN PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Extracorporeal membrane oxygenation; Critically ill children; Ventilation practice; Extracorporeal lief support
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: Ped.ECMO.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No