PRactice of VENTilation in Critically Ill PEDiatric Patients

Critical Illness Clinical Trial

— PRoVent-PED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06220825
• Other study ID #: PRoVent-PED
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2034

Study information

• Verified date: January 2024
• Source: University Medical Center Groningen
• Contact: Relin Van Vliet, MSc
• Phone: 0031627560257
• Email: r.vanvliet[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: April 1, 2034
• Est. primary completion date: April 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type of ventilatory support	Type of ventilatory support	First four days of (non-)invasive respiratory support
Other	Type of ventilator mode	Ventilator mode	First four days of (non-)invasive respiratory support
Other	Use of sedative and/or analgesic drugs (yes/no)	Use of sedative and/or analgesic drugs	First four days of (non-)invasive respiratory support
Other	Use of neuromuscular blocking agents (yes/no)	Use of neuromuscular blocking agents	First four days of (non-)invasive respiratory support
Other	Use of vasoactive infusions (yes/no)	Use of vasoactive infusions	First four days of (non-)invasive respiratory support
Other	Use of prone positioning (yes/no)	Use of prone positioning	First four days of (non-)invasive respiratory support
Other	Use of ECMO (yes/no)	Use of ECMO	First four days of (non-)invasive respiratory support
Primary	Tidal volume	Tidal volume	First four days of (non-)invasive respiratory support
Primary	Peak inspiratory pressure	Peak inspiratory pressure	First four days of (non-)invasive respiratory support
Primary	Plateau pressure	Pateau pressure	First four days of (non-)invasive respiratory support
Primary	Positive end-expiratory pressure	Positive end-expiratory pressure	First four days of (non-)invasive respiratory support
Primary	Driving pressure	Driving pressure	First four days of (non-)invasive respiratory support
Primary	Mechanical power	Mechanical power	First four days of (non-)invasive respiratory support
Secondary	PARDS prevalence	Prevalence of PARDS per PALICC-2 definition	First four days of (non-)invasive respiratory support
Secondary	Duration of respiratory support (in days)	Duration of respiratory support (in days)	Up to 28 days following initiation of (non-)invasive respiratory support
Secondary	Ventilator-free days at day 28	Ventilator-free days at day 28	Up to 28 days following initiation of (non-)invasive respiratory support
Secondary	Length of ICU stay (in days)	Length of ICU stay (in days)	PICU admission
Secondary	ICU mortality	ICU mortality	Up to 28 days following initiation of (non-)invasive respiratory support

External Links

•   PRoVent-PED study website