An observational study in Critical Illness and Respiratory Failure, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by University Medical Center Groningen · Observational
The goal of this worldwide observational study is to investigate ventilation practice in critically ill pediatric patients. The main questions it aims to answer are:
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.
Objectives:
Hypothesis:
Study design:
International, multicenter, observational cohort study in critically ill pediatric patients. 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. The study is designed to run for 10 years; within these 10 years, there will be subprojects during pre-defined periods. Centers have the option to opt out during certain time periods to make the study manageable for every participating country/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. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Critically ill pediatric patients
Exclusion Criteria:
Tidal volume
Tidal volume
Time frame: First four days of (non-)invasive respiratory support
Peak inspiratory pressure
Peak inspiratory pressure
Time frame: First four days of (non-)invasive respiratory support
Plateau pressure
Pateau pressure
Time frame: First four days of (non-)invasive respiratory support
Positive end-expiratory pressure
Positive end-expiratory pressure
Time frame: First four days of (non-)invasive respiratory support
Driving pressure
Driving pressure
Time frame: First four days of (non-)invasive respiratory support
Mechanical power
Mechanical power
Time frame: First four days of (non-)invasive respiratory support
PARDS prevalence
Prevalence of PARDS per PALICC-2 definition
Time frame: First four days of (non-)invasive respiratory support
Duration of respiratory support (in days)
Duration of respiratory support (in days)
Time frame: Up to 28 days following initiation of (non-)invasive respiratory support
Ventilator-free days at day 28
Ventilator-free days at day 28
Time frame: Up to 28 days following initiation of (non-)invasive respiratory support
Length of ICU stay (in days)
Length of ICU stay (in days)
Time frame: PICU admission
ICU mortality
ICU mortality
Time frame: Up to 28 days following initiation of (non-)invasive respiratory support
Type of ventilatory support
Type of ventilatory support
Time frame: First four days of (non-)invasive respiratory support
Type of ventilator mode
Ventilator mode
Time frame: First four days of (non-)invasive respiratory support
Use of sedative and/or analgesic drugs (yes/no)
Use of sedative and/or analgesic drugs
Time frame: First four days of (non-)invasive respiratory support
Use of neuromuscular blocking agents (yes/no)
Use of neuromuscular blocking agents
Time frame: First four days of (non-)invasive respiratory support
Use of vasoactive infusions (yes/no)
Use of vasoactive infusions
Time frame: First four days of (non-)invasive respiratory support
Use of prone positioning (yes/no)
Use of prone positioning
Time frame: First four days of (non-)invasive respiratory support
Use of ECMO (yes/no)
Use of ECMO
Time frame: First four days of (non-)invasive respiratory support
Plan to share: Yes
Supporting information: Study protocol, Sap
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University Medical Center Groningen