Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?
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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: Post Extubation Stridor. 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
- Бельгия
- Следующий шаг
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Официальное название
PES: Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?
Обзор
Post extubation stridor (PES) is a common and possibly serious complication of invasive ventilation via endotracheal tube (ETT) in pediatric intensive care (PICU) patients. The source of the PES is either temporary in the case of post-intubation laryngeal edema, or long-term in the case of subglottic stenosis.
Подробное описание
Post extubation stridor (PES) is a common and possibly serious complication of invasive ventilation via endotracheal tube (ETT) in pediatric intensive care (PICU) patients. The source of the PES is either temporary in the case of post-intubation laryngeal edema, or long-term in the case of subglottic stenosis.
Patients with PES could be in acute respiratory distress and failure requiring: 1. Medical Intervention (i.e. nebulized adrenaline, steroids or need for re-intubation), 2. Diagnostic Procedures (direct laryngoscopy) or 3. Temporary or permanent surgical airway - all leading to longer admissions and possible long term complications.
Several studies have tried to determine whether the development of PES is predictable using a airleak test (ALT) where a standardized test - measuring ETT leakage after deflating the ETT cuff- is performed once or multiple times just prior to extubation. Results have been contradictory to say the least (ref).
Based on current literature two questions arise. First; do we need to look at ETT leakage with a deflated - as is common practice in airleak tests - cuff? Or is the presence or absence of ETT leakage with an inflated cuff predictive for the development of PES? Second; airleak tests provide merely a snapshot -a trend measurement can possibly offer greater insight - especially using high resolution data. Would looking at the ETT leak trend for a longer period prior to extubation provide a clearer predictive value for the development of PES? The aim of our study is to answer these question and to determine if high resolution endotracheal tube leak data is predictive of the development of post-extubation stridor in children.
Analysis Airleak (% inspiratory tidal volume - expiratory tidal volume) will be calculated every minute in the 12 hours prior to extubation. Both magnitude (airleak %) and exposure (time) will be examined and plotted for patients with and without post-extubation stridor (primary outcome).
Первичные конечные точки
- Post-Extubation Stridor [Срок оценки: during ICU admission]
Вторичные конечные точки (3)
- Reintubation [Срок оценки: during ICU admission]
- Diagnostic procedure [Срок оценки: during ICU admission]
- Surgical airway [Срок оценки: during ICU admission]
Критерии участия
Критерии включения
- Age 0 - 16 years
- Ventilation via endotracheal tube for at least 6 hours
Критерии исключения
- None
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 1 центр
- Antwerp University Hospital — Antwerp
Публикации
- Wratney AT, Benjamin DK Jr, Slonim AD, He J, Hamel DS, Cheifetz IM. The endotracheal tube air leak test does not predict extubation outcome in critically ill pediatric patients. Pediatr Crit Care Med. 2008 Sep;9(5):490-6. doi: 10.1097/PCC.0b013e3181849901. PMID 18679147
- Mhanna MJ, Zamel YB, Tichy CM, Super DM. The "air leak" test around the endotracheal tube, as a predictor of postextubation stridor, is age dependent in children. Crit Care Med. 2002 Dec;30(12):2639-43. doi: 10.1097/00003246-200212000-00005. PMID 12483052
- Kemper KJ, Benson MS, Bishop MJ. Predictors of postextubation stridor in pediatric trauma patients. Crit Care Med. 1991 Mar;19(3):352-5. doi: 10.1097/00003246-199103000-00012. PMID 1999096
- Jaber S, Chanques G, Matecki S, Ramonatxo M, Vergne C, Souche B, Perrigault PF, Eledjam JJ. Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Med. 2003 Jan;29(1):69-74. doi: 10.1007/s00134-002-1563-4. Epub 2002 Nov 22. PMID 12528025
- Suominen PK, Tuominen NA, Salminen JT, Korpela RE, Klockars JG, Taivainen TR, Meretoja OA. The air-leak test is not a good predictor of postextubation adverse events in children undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2007 Apr;21(2):197-202. doi: 10.1053/j.jvca.2006.01.007. Epub 2006 Apr 19. PMID 17418731
- Schneider J, Mulale U, Yamout S, Pollard S, Silver P. Impact of monitoring endotracheal tube cuff leak pressure on postextubation stridor in children. J Crit Care. 2016 Dec;36:173-177. doi: 10.1016/j.jcrc.2016.06.033. Epub 2016 Jul 9. PMID 27546768
- Lacarra B, Hayotte A, Naudin J, Maroni A, Geslain G, Poncelet G, Levy M, Resche-Rigon M, Dauger S. Air leak test in the Paediatric Intensive Care Unit (ALTIPICU): rationale and protocol for a prospective multicentre observational study. BMJ Open. 2024 Apr 30;14(4):e081314. doi: 10.1136/bmjopen-2023-081314. PMID 38688666
Идентификаторы
NCT: NCT07414472 · Edge 004162