NCT06220825

PRactice of VENTilation in Critically Ill PEDiatric Patients

PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVENT-PED) - an International Multicenter Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. What is the global current practice of ventilatory support in critically ill pediatric patients? 2. Which potentially modifiable factors related to ventilation are associated with outcome? Participating pediatric intensive care units will gather detailed information about ventilation practice and outcome, such as duration of ventilatory support, length of ICU stay and ICU mortality.

Detailed description

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: 1. To describe the worldwide practice of ventilatory support in critically ill pediatric patients; and 2. To identify potentially modifiable ventilation parameters that have independent associations with outcome. Hypothesis: 1. Practice of ventilatory support in critically ill pediatric patients varies substantially worldwide; and 2. Potentially modifiable factors related to ventilation have independent associations with outcome in critically ill pediatric patients. 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.

Conditions

• Critical Illness
• Respiratory Failure

Timeline

• Start date: 2024-04-01
• Primary completion: 2034-04-01
• Completion: 2034-04-01
• First posted: 2024-01-24
• Last updated: 2025-02-07

Locations

1 site across 1 country: Netherlands