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NCT Number: NCT06899009

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Netherlands

About this study

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:

  • 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

Hypothesis:

  • Ventilation intensity decreases following initiation of ECMO; and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients (aged ≥29 days to ≤18 years) receiving ECMO between January 1, 2012, and December 31, 2022, in an ELSO affiliated center; and
  • Requiring ECMO for a pulmonary indication.

Exclusion criteria

  • Patients with missing ventilatory variables required to assess ventilation intensity;
  • patients who were lost to follow up with respect to hospital mortality.

Treatment and study plan

Primary outcomes

  1. Hospital mortality

    Time frame: Up to 90 days of study or whatever comes first

Secondary outcomes

  1. Hospital length of stay

    Time frame: Up to 90 days of study or whatever comes first

  2. Duration of ECMO run

    Time frame: Up to 90 days of study or whatever comes first

  3. Duration of invasive ventilation

    Time frame: Up to 90 days of study or whatever comes first

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study title

Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure - a Posthoc Analysis of the ELSO Registry

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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