- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01502111
Airway Management Study in Physician Manned Helicopter Emergency Medical Services (AIRPORT)
Improved Knowledge Through Better Data, Implementing and Evaluating a Novel Consensus-based Template for Uniform Reporting of Data From Pre-hospital Airway Management - a Prospective Multicentre Observational Study
Обзор исследования
Статус
Подробное описание
Advanced airway management and ventilatory control is generally regarded as vital in the management of seriously ill or injured patients, and can be critical interventions in patients with out-of-hospital emergencies. However, interventions like endotracheal intubation suffer from lack of clear evidence of a beneficial effect. Despite the publication of numerous airway management studies, inconsistent and imprecise reporting of data across heterogenous patient populations and EMS systems persists. The questions of how, and by whom, pre-hospital advanced airway management should be performed remains disputed.
Several authors have proposed appropriate guidelines and algorithms for management of prehospital airway and difficult intubation. The guidelines emphasize the importance of promoting patient safety and avoiding errors, and also recognise the importance of rescuers level of airway skills competence. Drug-assisted rapid sequence intubation (RSI) is an important, but potentially harmful, component of prehospital advanced airway management in EMS services. Even physicians working in the prehospital scene may find it challenging to maintain an adequate level of advanced airway competence in order to stay proficient. Better training methods and systems are warranted.
The recognition of endotracheal intubation as a "complex intervention" marks the need for an international standard for documenting and reporting data from prehospital intubations in severely injured or ill patients, alongside a standardization of research data collection to eliminate confounding factors. An international airway management expert group has recently developed an Utstein-style template for uniform reporting of data from prehospital advanced airway management. Implementing and validating the template will result in a high quality dataset and allow for research cooperation and comparison of airway management practice between EMS systems, and across different patient populations. Such a dataset will hopefully contribute to new knowledge in the field of prehospital advanced airway management.
The specific aims for the first two studies in this project are defined as follows:
- Describe the characteristics and outcome of advanced prehospital airway management in Helicopter Emergency Medical Services (HEMS) that provide the full range of advanced emergency airway management.
- Identify which groups of critically injured or ill patients will benefit most from competent advanced prehospital airway management, and identify specific areas for future research.
In this multicentre study, we have enlisted 21 key international HEMS services from 6 countries (UK, Australia, Hungary, Finland, Switzerland and Norway), and will collect data according to the Utstein style template over a 12 month study period starting January 1, 2012.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Drøbak, Норвегия, 1441
- Department of Research and Development, Norwegian Air Ambulance Foundation
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period.
Data reported according to the Utstein style template for uniform reporting of data from prehospital advanced airway management
Описание
Inclusion Criteria:
- All patients requiring and receiving prehospital advanced airway management on HEMS primary missions.
- Advanced airway management is defined as the attempted insertion of an advanced airway adjunct (including endotracheal intubation, alternative airways, and surgical airway /cricothyroidectomy) or the administration of ventilatory assistance/support (including bag-mask ventilation-BMV, BIPAP/CPAP or other ventilatory support).
- Advanced prehospital advanced airway management is further defined as any airway management beyond manual opening of the airway and use of simple airway adjuncts, such as a Guedel airway or supplemental oxygen
Exclusion Criteria:
- Patients receiving advanced airway management during so-called secondary missions (or inter-hospital transfer).
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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Airway management
Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Number of participants who survive to hospital admission
Временное ограничение: Time from injury/illness to admission hospital, up to 24 hours
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Time from injury/illness to admission hospital, up to 24 hours
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Number of participants with adverse events during airway interventions
Временное ограничение: Time from injury/illness to admission hospital, up to 24 hours
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Airway intervention success rates and airway management related complications.
We will calculate airway intervention success rates, frequency and complications for the entire cohort and for key subsets (like cardiac arrest, medical, trauma, pediatric patients and RSI/alternative airways), population demographics and prevalence of adverse effects (like missed intubations, bradycardia, hypotension, hypoxia).
Outcome and patient characteristics will be analysed and described.
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Time from injury/illness to admission hospital, up to 24 hours
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Geir A Sunde, MD, Norwegian Air Ambulance Foundation
- Учебный стул: Stephen Sollid, MD, PhD, Norwegian Air Ambulance Foundation
Публикации и полезные ссылки
Общие публикации
- Sunde GA, Sandberg M, Lyon R, Fredriksen K, Burns B, Hufthammer KO, Roislien J, Soti A, Jantti H, Lockey D, Heltne JK, Sollid SJM. Hypoxia and hypotension in patients intubated by physician staffed helicopter emergency medical services - a prospective observational multi-centre study. BMC Emerg Med. 2017 Jul 11;17(1):22. doi: 10.1186/s12873-017-0134-5.
- Sunde GA, Heltne JK, Lockey D, Burns B, Sandberg M, Fredriksen K, Hufthammer KO, Soti A, Lyon R, Jantti H, Kamarainen A, Reid BO, Silfvast T, Harm F, Sollid SJ; Airport Study Group. Airway management by physician-staffed Helicopter Emergency Medical Services - a prospective, multicentre, observational study of 2,327 patients. Scand J Trauma Resusc Emerg Med. 2015 Aug 7;23:57. doi: 10.1186/s13049-015-0136-9.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- NLA-3104-01/02
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