CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation
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
- В протоколе указаны: tracheal intubation.
- Кому может быть актуально
- Состояния в реестре: Intubation Complication, Adverse Events. Базовые параметры: до 16 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
- США, Австралия, Канада, Германия, Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The investigators' overall objective is to assess the incidence of critical events related to tracheal intubation at all international study sites. Furthermore, the study will investigate the used intubation techniques and identify possible improvement measures to increase patient safety.
Подробное описание
It is a prospective observational multi-centre study collecting health related patient data over a period of three months. This serves best the study's purpose to detect the incidence and nature of problems related to tracheal intubation and how such problems are handled with the aim to further improve patient safety. During the observational period the anaesthesia staff in charge will complete a screening questionnaire for critical events associated with tracheal intubation for every patient undergoing general anaesthesia with tracheal intubation. If no critical events arise there are no further requirements. If a critical event occurs, the anaesthesia provider will complete a more detailed questionnaire which includes more questions about what exactly happened.
Patient characteristics will be extracted from the anaesthesia records. The investigators will extract such data for all patients undergoing tracheal intubation and additional data for those with critical events. The research will not intervene with the clinical conduct of patient care.
The collected health related data will be transferred to an electronic research data base. In this data base data will be encoded. Every patient with a critical event will be followed up as described above.
Вмешательства
- Другое tracheal intubation
children between 0-16 requiring tracheal intubation
Первичные конечные точки
- Number of patients with critical events related to intubation [Срок оценки: Maximum of 30 days]
Вторичные конечные точки (12)
- Number of patients with severe hypoxemia [Срок оценки: 1 hour]
- Number of patients with severe bradycardia [Срок оценки: 1 hour]
- Number of patients with esophageal intubation [Срок оценки: 1 hour]
- Number of patients with laryngospasm [Срок оценки: 1 hour]
- Number of patients with bronchospasm [Срок оценки: 1 hour]
- Number of patients with stridor after extubation [Срок оценки: 1 hour]
- Number of patients with obstruction of tracheal tube [Срок оценки: 1 hour]
- Number of patients with airway bleeding [Срок оценки: 1 hour]
- Number of patients with can't intubate, can't oxygenate (CICO) situation [Срок оценки: 1 hour]
- Number of patients with severe bradycardia/Cardiac arrest [Срок оценки: 1 hour]
- Number of patients with pulmonary aspiration [Срок оценки: 1 hour]
- Number of patients with pneumothorax/ pneumomediastinum [Срок оценки: 1 hour]
Критерии участия
Критерии включения
- All paediatric patients requiring tracheal intubation, performed by the anaesthesia team for procedures or interventions requiring general anaesthesia
- Patients from 0 - 16 years of age.
- Informed or general consent given, according to the relevant ethics committee statement.
Критерии исключения
- Refusal to give consent or withdrawal of consent if such is required by the relevant ethics committee.
- Patients >16 years
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 2 центра
- Department of Anesthesiology, Critical Care and Pain Medicine — Boston
- Dept of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia — Philadelphia
Канада · 2 центра
- Dept. Anesthesia, The Hospital for Sick Children — Toronto
- Dept. Anesthesia, Montreal Children's Hospital, McGill University Health Centre — Montreal
Швейцария · 2 центра
- Unité d'anesthésie pédiatrique, Hôpital des Enfants / HUG — Geneva
- Children's Hospital Zurich — Zurich
Австралия · 1 центр
- Department of Anaesthesia and Pain Management, Perth Children's Hospital — Perth
Германия · 1 центр
- Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Universitätsmedi — Berlin
Публикации
- Bennett T, Disma N, Engelhardt T, Fiadjoe J, Fuchs A, Garcia-Marcinkiewicz A, Gregori D, Greif R, Habre W, Lorenzoni G, Kleine-Brueggeney M, Matava C, Maria Papappicco CA, Quintao VC, Riva T, von Ungern-Sternberg BS, Zoumenou E. Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation (CRICKET)-study protocol for an international multicentre prospective observational study. BJA Open. 2 PMID 41705042
Идентификаторы
NCT: NCT05804188 · Cricket 2023 · 2023-00246