Clinical trial NCT06220825: PRactice of VENTilation in Critically Ill PEDiatric Patients
Official title: PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVENT-PED) - an International Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Respiratory Failure
Keywords: Ventilation practice
Critically ill children
PARDS
Mechanical ventilation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2024-01-24
Enrollment: 2500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill pediatric patients

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Tidal volume
timeFrame: First four days of (non-)invasive respiratory support
measure: Peak inspiratory pressure
timeFrame: First four days of (non-)invasive respiratory support
measure: Plateau pressure
timeFrame: First four days of (non-)invasive respiratory support
measure: Positive end-expiratory pressure
timeFrame: First four days of (non-)invasive respiratory support
measure: Driving pressure
timeFrame: First four days of (non-)invasive respiratory support
measure: Mechanical power
timeFrame: First four days of (non-)invasive respiratory support
Secondary outcomes:
measure: PARDS prevalence
timeFrame: First four days of (non-)invasive respiratory support
measure: Duration of respiratory support (in days)
timeFrame: Up to 28 days following initiation of (non-)invasive respiratory support
measure: Ventilator-free days at day 28
timeFrame: Up to 28 days following initiation of (non-)invasive respiratory support
measure: Length of ICU stay (in days)
timeFrame: PICU admission
measure: ICU mortality
timeFrame: Up to 28 days following initiation of (non-)invasive respiratory support
Other outcomes:
measure: Type of ventilatory support
timeFrame: First four days of (non-)invasive respiratory support
measure: Type of ventilator mode
timeFrame: First four days of (non-)invasive respiratory support
measure: Use of sedative and/or analgesic drugs (yes/no)
timeFrame: First four days of (non-)invasive respiratory support
measure: Use of neuromuscular blocking agents (yes/no)
timeFrame: First four days of (non-)invasive respiratory support
measure: Use of vasoactive infusions (yes/no)
timeFrame: First four days of (non-)invasive respiratory support
measure: Use of prone positioning (yes/no)
timeFrame: First four days of (non-)invasive respiratory support
measure: Use of ECMO (yes/no)
timeFrame: First four days of (non-)invasive respiratory support
Locations:
city: Groningen
country: Netherlands
facility: UMC Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Martin CJ Kneyber, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Marcus J Schultz, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Frederique Paulus, RN PhD
role: PRINCIPAL_INVESTIGATOR
References: