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NCT Number: NCT06220825

PRactice of VENTilation in Critically Ill PEDiatric Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Groningen

Groningen, Netherlands

Location status: Recruiting

Location contact

Martin CJ Kneyber

CONTACT

0031503614215

About this study

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:

  • To describe the worldwide practice of ventilatory support in critically ill pediatric patients; and
  • To identify potentially modifiable ventilation parameters that have independent associations with outcome.

Hypothesis:

  • Practice of ventilatory support in critically ill pediatric patients varies substantially worldwide; and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Tidal volume

    Time frame: First four days of (non-)invasive respiratory support

    Tidal volume

  2. Peak inspiratory pressure

    Time frame: First four days of (non-)invasive respiratory support

    Peak inspiratory pressure

  3. Plateau pressure

    Time frame: First four days of (non-)invasive respiratory support

    Pateau pressure

  4. Positive end-expiratory pressure

    Time frame: First four days of (non-)invasive respiratory support

    Positive end-expiratory pressure

  5. Driving pressure

    Time frame: First four days of (non-)invasive respiratory support

    Driving pressure

  6. Mechanical power

    Time frame: First four days of (non-)invasive respiratory support

    Mechanical power

Secondary outcomes

  1. PARDS prevalence

    Time frame: First four days of (non-)invasive respiratory support

    Prevalence of PARDS per PALICC-2 definition

  2. Duration of respiratory support (in days)

    Time frame: Up to 28 days following initiation of (non-)invasive respiratory support

    Duration of respiratory support (in days)

  3. Ventilator-free days at day 28

    Time frame: Up to 28 days following initiation of (non-)invasive respiratory support

    Ventilator-free days at day 28

  4. Length of ICU stay (in days)

    Time frame: PICU admission

    Length of ICU stay (in days)

  5. ICU mortality

    Time frame: Up to 28 days following initiation of (non-)invasive respiratory support

    ICU mortality

Other outcomes

  1. Type of ventilatory support

    Time frame: First four days of (non-)invasive respiratory support

    Type of ventilatory support

  2. Type of ventilator mode

    Time frame: First four days of (non-)invasive respiratory support

    Ventilator mode

  3. Use of sedative and/or analgesic drugs (yes/no)

    Time frame: First four days of (non-)invasive respiratory support

    Use of sedative and/or analgesic drugs

  4. Use of neuromuscular blocking agents (yes/no)

    Time frame: First four days of (non-)invasive respiratory support

    Use of neuromuscular blocking agents

  5. Use of vasoactive infusions (yes/no)

    Time frame: First four days of (non-)invasive respiratory support

    Use of vasoactive infusions

  6. Use of prone positioning (yes/no)

    Time frame: First four days of (non-)invasive respiratory support

    Use of prone positioning

  7. Use of ECMO (yes/no)

    Time frame: First four days of (non-)invasive respiratory support

    Use of ECMO

Study contacts

Contact information is provided by the study sponsor or research team.

David MP van Meenen, MD PhD

CONTACT

[email protected]

Relin Van Vliet, MSc

CONTACT

[email protected]

0031627560257

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study title

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

Acronym: PRoVent-PED

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Jan 24, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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