PRactice of VENTilation in Critically Ill PEDiatric Patients

Recruiting

• Conditions: Critical Illness; Respiratory Failure

• Registration Number: NCT06220825
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-24
• Study Start: 2024-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2034-04-01
• Study Completion: 2034-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Expected use of (non-)invasive respiratory support for at least 12 hrs

Exclusion Criteria

• premature infants (i.e., postconceptional age corrected for gestational age < 40 weeks)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak inspiratory pressure	First four days of (non-)invasive respiratory support	Peak inspiratory pressure
Plateau pressure	First four days of (non-)invasive respiratory support	Pateau pressure
Driving pressure	First four days of (non-)invasive respiratory support	Driving pressure
Mechanical power	First four days of (non-)invasive respiratory support	Mechanical power
Positive end-expiratory pressure	First four days of (non-)invasive respiratory support	Positive end-expiratory pressure
Tidal volume	First four days of (non-)invasive respiratory support	Tidal volume

Secondary Outcome Measures

Name	Time	Method
Duration of respiratory support (in days)	Up to 28 days following initiation of (non-)invasive respiratory support	Duration of respiratory support (in days)
ICU mortality	Up to 28 days following initiation of (non-)invasive respiratory support	ICU mortality
Ventilator-free days at day 28	Up to 28 days following initiation of (non-)invasive respiratory support	Ventilator-free days at day 28
Length of ICU stay (in days)	PICU admission	Length of ICU stay (in days)
PARDS prevalence	First four days of (non-)invasive respiratory support	Prevalence of PARDS per PALICC-2 definition

Trial Locations

Locations (1)

UMC Groningen; 🇳🇱 Groningen, Netherlands