EXtubation Related Complications - the EXTUBE Study (EXTUBE)
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: Extubation. Базовые параметры: от 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
- США, Австралия, Канада, Колумбия, Ирландия +3
- 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
EXtubation Related Complications - an International Observational Study To Understand the Impact and BEst Practices in the Operating Room and Intensive Care Unit - the EXTUBE Study
Обзор
EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).
Подробное описание
Globally, over 200 million people each year require extubation. While routinely performed, extubation is a skilled and potentially high-risk procedure that should be performed only when physiologic, pharmacologic, and contextual conditions are optimal. Complications at this stage of patient care can result in decreased oxygen delivery to the brain and body, sometimes leading to serious adverse events such as cardiac arrest, brain damage, or death. Indeed, one quarter of airway complications that result in death or brain death occur at the time of extubation.
Despite the frequency of extubation and the potential for life-threatening complications, there is a lack of systematic data on the rate and circumstances under which these severe complications occur. The limited data indicate 10-30% of extubations may lead to severe complications, depending on the population and outcome definition. However, the certainty of these estimates is severely limited because they are based on studies that are small, mostly single-center, based on clinician recall, only capture a small portion of extubation complications (e.g., malpractice claims), or do not reflect current clinical practice. In addition, most lack a denominator and exclude successful extubations, making estimates of actual complication rates and risk factors impossible.
There has been no large study of extubation techniques or adherence to guidelines, so procedural factors associated with complications must be elucidated. While adherence to clinical practice guidelines has not been formally evaluated, surveys show non-adherence to some best practices and considerable variation in practice, and data from audits and medicolegal claims show that lack of adherence to best practices is frequently at the root cause of severe adverse extubation outcomes, with half of the complications deemed preventable. Therefore, data on the frequency and nature of extubation complications, patient and procedural risk factors for complications, and guideline adherence rates are needed before these preventable events can be addressed.
EXTUBE (EXtubation related complications - an international observational study To Understand the impact and BEst practices in the operating room and intensive care unit) is an international, multicenter, prospective cohort study
The primary objective of this study is to estimate the incidence of immediate complications related to extubation in adult patients after general anesthesia and/or after critical illness. The secondary objectives are to determine: 1) the incidence of mild extubation complications; 2) patient- and procedure-related risk factors for extubation complications; 3) the association between extubation complications and outcomes until hospital discharge; and 4) the rate of adherence to extubation clinical practice guidelines.
Первичные конечные точки
- At least one of the following, occurring within 60minutes after extubation (composite outcome): i) Severe hypoxemia ii) Cardiac arrest iii) Need for airway management [Срок оценки: Within 60 minutes after the end of extubation]
Вторичные конечные точки (12)
- Difficult airway and complications related to airway management if reintubation is required [Срок оценки: Within 60 minutes after the end of extubation]
- Planned and unplanned non-invasive respiratory support [Срок оценки: Within 60 minutes after the end of extubation]
- Emergency front of neck airway [Срок оценки: Within 60 minutes after the end of extubation]
- Cardiac arrhythmia requiring chemical or electrical treatment [Срок оценки: Within 60 minutes after the end of extubation]
- Severe Hypotension [Срок оценки: Within 60 minutes after the end of extubation]
- Severe Hypertension [Срок оценки: Within 60 minutes after the end of extubation]
- Pulmonary aspiration [Срок оценки: Within 60 minutes after the end of extubation]
- Barotrauma [Срок оценки: Within 60 minutes after the end of extubation]
- Dental injury [Срок оценки: Within 60 minutes after the end of extubation]
- Airways injury [Срок оценки: Within 60 minutes after the end of extubation]
- Mortality [Срок оценки: Within 7 days after extubation]
- Re-intubation [Срок оценки: Within 48 hours after extubation]
Критерии участия
Критерии включения
- Adult patients (≥18 years old)
- Undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU
- Undergoing extubation during the specified enrollment window
Критерии исключения
- Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,
- Patients will be excluded if the extubation is performed for tracheostomy decannulation
For each patient who is not included, reasons for exclusion will be reported.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 9 центров
- Surrey Memorial Hospital — Surrey
- The Moncton Hospital — Moncton
- Sunnybrook Hospital — North York
- Niagara Health - Marotta Family Hospital — Saint Catharines
- St. Michael's Hospital — Toronto
- Mount Sinai Hospital — Toronto
- University Health Network - Toronto General Hospital — Toronto
- University Health Network - Toronto Western Hospital — Toronto
- … и ещё 1 центр
США · 6 центров
- Banner University Medical Centre — Tucson
- University of Arkansas for Medical Sciences — Little Rock
- University of Florida — Gainesville
- The University of Chicago — Chicago
- Oregon Health & Science University — Portland
- The University of Texas Health Science Center — Houston
Австралия · 6 центров
- Royal North Shore Hospital — Sydney
- The Northern Hospital — Melbourne
- Austin Hospital — Melbourne
- Eastern Health - Box Hill Hospital — Melbourne
- Eastern Health - Maroondah Hospital — Melbourne
- Eastern Health - Angliss Hospital — Melbourne
Ирландия · 5 центров
- Mayo University Hospital — Castlebar
- Cork University Hospital — Cork
- Mater Misericordiae University Hospital — Dublin
- Galway University Hospitals — Galway
- University Hospital Waterford — Waterford
Новая Зеландия · 2 центра
- Southland Hospital — Invercargill
- Rotorua Hospital — Rotorua
Великобритания · 2 центра
- Royal United Hospitals Bath — Bath
- Freeman Hospital — Newcastle upon Tyne
Колумбия · 1 центр
- Hospital Internacional de Colombia — Piedecuesta
Сингапур · 1 центр
- Tan Tock Seng Hospital — Singapore
Идентификаторы
NCT: NCT06442930 · 24-5811 · 4850