PRactice of VENTilation in Critically Ill PEDiatric Patients

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06220825
Study type	Observational
Source	University Medical Center Groningen
Contact	Relin Van Vliet, MSc
Phone	0031627560257
Email	r.vanvliet@amsterdamumc.nl
Status	Not yet recruiting
Phase
Start date	April 1, 2024
Completion date	April 1, 2034

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PRactice of VENTilation in Critically Ill PEDiatric Patients — PRoVent-PED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms