PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVent-PED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Respiratory Failure

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 Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Relin Van Vliet, MSc; Phone Number: 0031627560257; Email: r.vanvliet@amsterdamumc.nl
• Study Contact Backup: Name: David MP van Meenen, MD PhD; Email: d.m.vanmeenen@amsterdamumc.nl

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Recruiting
    • UMC Groningen
    • Contact: Martin CJ Kneyber; Phone Number: 0031503614215

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill pediatric patients

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of ventilatory support	Type of ventilatory support	First four days of (non-)invasive respiratory support
Type of ventilator mode	Ventilator mode	First four days of (non-)invasive respiratory support
Use of sedative and/or analgesic drugs (yes/no)	Use of sedative and/or analgesic drugs	First four days of (non-)invasive respiratory support
Use of neuromuscular blocking agents (yes/no)	Use of neuromuscular blocking agents	First four days of (non-)invasive respiratory support
Use of vasoactive infusions (yes/no)	Use of vasoactive infusions	First four days of (non-)invasive respiratory support
Use of prone positioning (yes/no)	Use of prone positioning	First four days of (non-)invasive respiratory support
Use of ECMO (yes/no)	Use of ECMO	First four days of (non-)invasive respiratory support

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Martin CJ Kneyber, MD PhD, University Medical Center Groningen; Principal Investigator: Marcus J Schultz, MD PhD, Amsterdam UMC; Principal Investigator: Frederique Paulus, RN PhD, Amsterdam UMC

Publications and helpful links

Helpful Links

• PRoVent-PED study website

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Critically ill children; Ventilation practice; PARDS
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: PRoVent-PED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No