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Study Summary

Rationale

Studies on ventilatory support in critically ill pediatric patients remain scarce and much of the current clinical practice is based upon experience and data originating from critically ill adult patients. The aims of this study are to investigate practice of ventilatory support in critically ill pediatric patients and to identify potentially modifiable factors associated with outcome in order to optimize ventilation strategies, to design future clinical trials and to support the development of clinical practice guidelines.

Objective

To a) describe the practice of ventilatory support in critically ill pediatric patients, b) to identify potentially modifiable ventilation parameters that have independent associations with outcome and c) to study the prevalence of the Pediatric Acute Respiratory Distress Syndrome (PARDS).

Study design

Investigator–initiated, prospective, international, multicenter observational cohort study over a 10-year period. Each year, data will be collected in two predefined 4-week periods, one in the winter season and one in the summer season. A third 4-week period will be in case of epi- or pandemics. Centers have the option to opt out during certain time periods to make the study manageable for every participating center.

Study population

Critically ill pediatric patients (aged 0-18) admitted to the pediatric intensive care unit (PICU) and necessitating ventilatory support > 12 hours. Premature infants will be excluded.

Main study endpoints

The primary endpoint is a set of key ventilation settings and ventilation parameters. Secondary endpoints include the incidence of PARDS, duration of ventilatory support, the number of days free from ventilatory support at day 28, length of ICU stay, ICU mortality and potentially modifiable factors that have an independent association with outcome.

Ethical approval

The METC of the UMCG has decided that the study is not subject to the WMO. Since the study only prospectively collects data and no research related interventions will take place, participating in the study is without risk for the patient.

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