PRactice of VENTilation in Critically Ill PEDiatric Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Critical Illness, Respiratory Failure. Базовые параметры: до 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVENT-PED) - an International Multicenter Observational Study
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Tidal volume [Срок оценки: First four days of (non-)invasive respiratory support]
- Peak inspiratory pressure [Срок оценки: First four days of (non-)invasive respiratory support]
- Plateau pressure [Срок оценки: First four days of (non-)invasive respiratory support]
- Positive end-expiratory pressure [Срок оценки: First four days of (non-)invasive respiratory support]
- Driving pressure [Срок оценки: First four days of (non-)invasive respiratory support]
- Mechanical power [Срок оценки: First four days of (non-)invasive respiratory support]
Вторичные конечные точки (5)
- PARDS prevalence [Срок оценки: First four days of (non-)invasive respiratory support]
- Duration of respiratory support (in days) [Срок оценки: Up to 28 days following initiation of (non-)invasive respiratory support]
- Ventilator-free days at day 28 [Срок оценки: Up to 28 days following initiation of (non-)invasive respiratory support]
- Length of ICU stay (in days) [Срок оценки: PICU admission]
- ICU mortality [Срок оценки: Up to 28 days following initiation of (non-)invasive respiratory support]
Критерии участия
Критерии включения
- Expected use of (non-)invasive respiratory support for at least 12 hrs
Критерии исключения
- premature infants (i.e., postconceptional age corrected for gestational age < 40 weeks)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 1 центр
- UMC Groningen — Groningen
Публикации
- van Vliet R, Melger JWJ, Bem RA, Blokpoel RGT, Schultz MJ, Paulus F, Kneyber MCJ, van Meenen DMP; PRoVENT-PED steering committee and investigators. Epidemiology, ventilation management, and clinical outcomes in children (PRoVENT-PED): first results from the 10-year, investigator-initiated, international, multicentre, prospective cohort study. Lancet Respir Med. 2026 Jul;14(7):577-588. doi: 10.1016 PMID 42081907
Идентификаторы
NCT: NCT06220825 · PRoVent-PED