- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07726628
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea (TELEDYS)
Dyspnea is the subjective sensation of difficult or uncomfortable breathing. It accounts for approximately 10% of emergency department visits and 8% of calls to Emergency Medical Communication Centers. Nearly half of patients presenting with dyspnea require hospital admission, 15% require ventilatory support, and approximately 5% die. Early recognition of signs of respiratory severity is therefore essential to accurately assess clinical urgency, guide diagnostic evaluation, and inform appropriate management decisions.
In France, patients are encouraged to contact an Emergency Medical Communication Centers before presenting to an emergency department. Calls are managed by an emergency physician responsible for medical regulation, who performs a remote clinical assessment and determines the most appropriate level of care. Depending on the clinical evaluation, the physician may provide medical advice, refer the patient to an emergency department, dispatch emergency medical services, or send a physician-staffed mobile intensive care unit for life-threatening emergencies.
The remote assessment of patients presenting with dyspnea is particularly challenging. The inability to directly observe or examine the patient, combined with the caller's difficulty in accurately describing the clinical situation, may impair the recognition of disease severity and result in inappropriate triage decisions, including under-triage and over-triage :
Under-triage, characterized by failure to dispatch appropriate emergency resources or to refer the patient to an emergency department when indicated, may delay treatment and increase the risk of adverse outcomes, including mortality.
Conversely, over-triage, defined as unnecessary referral to primary care or emergency departments or inappropriate dispatch of emergency resources, contributes to emergency department overcrowding, inefficient use of prehospital resources, and increased healthcare costs.
In a previous study, we demonstrated that video-assisted medical triage improved emergency physicians' ability to assess the severity of patients presenting with acute dyspnea. This telemedicine tool enables real-time transmission of a live video stream from the caller's smartphone camera to the emergency physician through a secure digital platform, providing direct visualization of the patient's clinical condition. By enhancing remote clinical assessment, video-assisted triage has the potential to reduce both under-triage and over-triage.
In the present stepped-wedge cluster randomized trial, we hypothesized that incorporating real-time video support into the medical regulation of adult patients contacting an Emergency Medical Communication Centers for acute dyspnea would improve the quality of medical decision-making compared with standard telephone triage alone.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Nicolas MARJANOVIC
- Номер телефона: +33549441873
- Электронная почта: nicolas.marjanovic@chu-poitiers.fr
Учебное резервное копирование контактов
- Имя: Sabrina SEGUIN
- Номер телефона: +33549443229
- Электронная почта: sabrina.seguin@chu-poitiers.fr
Места учебы
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Poitiers, Франция, 86021
- University Hospital of Poitiers
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Контакт:
- Nicolas MARJANOVIC
- Номер телефона: +33549441873
- Электронная почта: nicolas.marjanovic@chu-poitiers.fr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Patients aged 18 or over
- Contacting the Emergency Medical Communication Center regarding acute dyspnea, respiratory distress or shortness of breath, as the main reason for the call, regardless of the underlying cause
- The patient or a bystander must have a mobile phone equipped with a camera and capable of making video calls
- Emergency inclusion authorized by the emergency physician responsible for medical regulation in accordance with the emergency consent procedure applicable at the time of the call
Exclusion Criteria:
- An immediate life-threatening emergency justifying the dispatch of an emergency response team on an automatic basis in accordance with local protocols
- Patient at the end of life or where a decision to limit treatment is known at the time of the call.
- Refusal to use telemedicine
- Lack of a telephone network enabling video consultation.
- Patient already included in the study.
- Individuals requiring enhanced protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, and adults under legal guardianship known at the time of the call
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Без вмешательства: Standard medical dispatching process (Control group)
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Экспериментальный: Addition of telemedecine to standard medical dispatching process (Experimental group)
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Patients included during the intervention phase will undergo video-assisted medical triage. Video-assisted triage will be performed using a secure web-based telemedicine hosted on a certified health data server. The emergency physician responsible for medical regulation will send a secure web link via SMS to the caller's smartphone or, when appropriate, to the smartphone of a relative or bystander. Once the link has been activated, a live video stream captured by the smartphone camera will be securely transmitted in real time to the physician's workstation at the Emergency Medical Communication Center, enabling direct visualization of the patient's clinical condition during the remote assessment. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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To determine whether the use of video-assisted medical triage improves the quality of medical decision-making during the regulation of adult patients contacting Emergency Medical Communication Center with acute dyspnea
Временное ограничение: 28 days
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To determine whether the use of video-assisted medical triage, based on real-time transmission from the caller's smartphone camera, improves the quality of medical decision-making during the regulation of adult patients contacting Emergency Medical Communication Center with acute dyspnea as their primary complaint by reducing the proportion of under-triage and over-triage. Definitions: Under-triage is defined as the assignment of a level of response that is insufficient for the patient's actual clinical needs. Over-triage is defined as the assignment of a level of response that exceeds the patient's actual clinical needs. |
28 days
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients experiencing under-triage
Временное ограничение: 28 days
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28 days
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients experiencing over-triage
Временное ограничение: 28 days
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28 days
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients requiring advanced respiratory support (defined as any oxygenation or ventilatory support beyond conventional oxygen therapy)
Временное ограничение: 3 hours, 24 hours, 28 days
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3 hours, 24 hours, 28 days
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients admitted to an intensive care unit
Временное ограничение: 24 hours
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24 hours
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients experiencing cardiac arrest
Временное ограничение: 3 hours, 24 hours, 28 days
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3 hours, 24 hours, 28 days
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To compare patients managed with and without video-assisted medical triage with respect to all-cause mortality
Временное ограничение: 3 hours, 24 hours, 28 days
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3 hours, 24 hours, 28 days
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To compare patients managed with and without video-assisted medical triage with respect to the total duration of the medical regulation process
Временное ограничение: Immediately after the procedure
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Immediately after the procedure
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Medical economic impact: cost-effectiveness study (difference in costs divided by the difference in effectiveness: cost/serious complication avoided)
Временное ограничение: 28 days
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28 days
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
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
- 2026-A00879-42
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .