NCT06220825

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. 1.What is the global current practice of ventilatory support in critically ill pediatric patients?
  2. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
96mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Apr 2024Apr 2034

First Submitted

Initial submission to the registry

January 8, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

10 years

First QC Date

January 8, 2024

Last Update Submit

February 4, 2025

Conditions

Critical IllnessRespiratory Failure

Keywords

Ventilation practiceCritically ill childrenPARDSMechanical ventilation

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (5)

  • PARDS prevalence

    First four days of (non-)invasive respiratory support

  • Duration of respiratory support (in days)

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

  • Ventilator-free days at day 28

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

  • Length of ICU stay (in days)

    PICU admission

  • ICU mortality

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

Other Outcomes (7)

  • Type of ventilatory support

    First four days of (non-)invasive respiratory support

  • Type of ventilator mode

    First four days of (non-)invasive respiratory support

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

    First four days of (non-)invasive respiratory support

  • +4 more other outcomes

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Critically ill pediatric patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Groningen

Groningen, Netherlands

RECRUITING

Related Links

MeSH Terms

Conditions

Critical IllnessRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Relin Van Vliet, MSc

CONTACT

0031627560257r.vanvliet@amsterdamumc.nl

David MP van Meenen, MD PhD

CONTACT

d.m.vanmeenen@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 24, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

April 1, 2034

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

NL(1)