Critical Illness, Respiratory Failure
Conditions
Keywords
Ventilation practice, Critically ill children, PARDS, Mechanical ventilation
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.
Interventions
None listed
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tidal volume | First four days of (non-)invasive respiratory support | Tidal volume |
| Mechanical power | First four days of (non-)invasive respiratory support | Mechanical power |
| Driving pressure | First four days of (non-)invasive respiratory support | Driving pressure |
| Positive end-expiratory pressure | First four days of (non-)invasive respiratory support | Positive end-expiratory pressure |
| Plateau pressure | First four days of (non-)invasive respiratory support | Pateau pressure |
| Peak inspiratory pressure | First four days of (non-)invasive respiratory support | Peak inspiratory pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free days at day 28 | Up to 28 days following initiation of (non-)invasive respiratory support | Ventilator-free days at day 28 |
| PARDS prevalence | First four days of (non-)invasive respiratory support | Prevalence of PARDS per PALICC-2 definition |
| Duration of respiratory support (in days) | Up to 28 days following initiation of (non-)invasive respiratory support | Duration of respiratory support (in days) |
| Length of ICU stay (in days) | PICU admission | Length of ICU stay (in days) |
| ICU mortality | Up to 28 days following initiation of (non-)invasive respiratory support | ICU mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Type of ventilator mode | First four days of (non-)invasive respiratory support | Ventilator mode |
| Use of ECMO (yes/no) | First four days of (non-)invasive respiratory support | Use of ECMO |
| Use of prone positioning (yes/no) | First four days of (non-)invasive respiratory support | Use of prone positioning |
| Use of vasoactive infusions (yes/no) | First four days of (non-)invasive respiratory support | Use of vasoactive infusions |
| Use of neuromuscular blocking agents (yes/no) | First four days of (non-)invasive respiratory support | Use of neuromuscular blocking agents |
| Type of ventilatory support | First four days of (non-)invasive respiratory support | Type of ventilatory support |
| Use of sedative and/or analgesic drugs (yes/no) | First four days of (non-)invasive respiratory support | Use of sedative and/or analgesic drugs |
Countries
Netherlands
Contacts
Primary ContactRelin Van Vliet, MSc
Backup ContactDavid MP van Meenen, MD PhD
Outcome results
None listed