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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Respiratory Failure (Pediatric Patients)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children with respiratory failure on ECMO

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No