Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2 июля 2012 г. обновлено: University Hospital, Grenoble
Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.
International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.
In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
Multicentric, prospective, controlled, randomized study with parallel groups in single blind.
Patients will be included in chronological periods to avoid selection biais (one month with the first medical device the next month with the other one). The determination of these periods will be centralized. The emergency vehicles will be supplied sufficiently with devices. This design has been chosen in order to answer to the emergency problem.
Patients will be included and ventilated by paramedical staff (first responders) before medical staff (Mobile Intensive Care Unit) intervention. Complete detailed information will be given to the patient or to the family and consent asked.
The comparison of no flow time between the two strategies in out of hospital cardiac arrest will be the following :
A : ventilation by bag valve mask and interrupted chest compression B : ventilation by laryngeal tube and continuous chest compression
Тип исследования
Интервенционный
Регистрация (Действительный)
84
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Isere
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Fontaine, Isere, Франция, 38602
- SDIS
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Grenoble, Isere, Франция, 38043
- Samu Smur
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
- more than 18 years
- patient affiliated to the social security system or equivalent
Exclusion Criteria:
- certain death
- patient deprived of freedom by judicial or administrative decision
- patient under legal protection
- Pregnancy, parturient or breast feeding
- facial trauma
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: ventilation by laryngeal tube
ventilation by laryngeal tube and continuous chest compression
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Comparison of no flow time between two strategies in out of hospital cardiac arrest
Другие имена:
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Фальшивый компаратор: ventilation by bag valve mask
ventilation by bag valve mask and interrupted chest compression
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Comparison of no flow time between two strategies in out of hospital cardiac arrest
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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comparison of no flow time between two strategies
Временное ограничение: arrival of paramedical staff T0
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group A : ventilation by bag valve mask and interrupted chest compression group B : ventilation by laryngeal tube and continuous chest compression outcome measure : time of no flow during Resuscitation by trained paramedical staff in out of hospital cardiac arrest |
arrival of paramedical staff T0
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
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No flow proportion during resuscitation by paramedical staff after emergency training
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
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no flow proportion on total resuscitation duration
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
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number of failure installation after 2 tests
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
|
Time of device installation
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
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chest expansion during insuflation (yes/no)
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
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Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
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incident during ventilation : obstruction number of manipulations to optimize ventilation |
during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
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ETCO2
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest at T0
|
Number of external electric shocks
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during cardiac arrest at T0
|
|
qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Временное ограничение: during cardiac arrest a T0
|
degradation due to technical manipulations
|
during cardiac arrest a T0
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Vincent Danel, MD, University Hospital, Grenoble
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 марта 2011 г.
Первичное завершение (Действительный)
1 февраля 2012 г.
Завершение исследования (Действительный)
1 июня 2012 г.
Даты регистрации исследования
Первый отправленный
11 февраля 2011 г.
Впервые представлено, что соответствует критериям контроля качества
11 февраля 2011 г.
Первый опубликованный (Оценивать)
14 февраля 2011 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
3 июля 2012 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
2 июля 2012 г.
Последняя проверка
1 июля 2012 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- DCIC - 1014
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .