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Diaphragm Hibernation and Its Driving Factors in Mechanically Ventilated ICU Patients (DISSECT)

14 сентября 2026 г. обновлено: Radboud University Medical Center

Diaphragm hIbernation and itS Driving factorS in mEChanically venTilated ICU Patients: the DISSECT Study

Rationale:

Patients with invasive mechanical ventilation (IMV) frequently develop diaphragm dysfunction and experience difficult weaning. Recent ex vivo work suggests that a subset of mechanically ventilated ICU patients may exhibit diaphragm hibernation, an energy conserving myosin state that reduces force generation and may lead to a reversible increase in diaphragm strength over time. However, it is unknown whether diaphragm hibernation can be demonstrated in vivo during IMV and which clinical and biological factors are associated with this phenotype.

Objective:

Primary objective is to determine the driving factors (biomarkers) of diaphragm hibernation during IMV. Secondary objectives are to determine the proportion of ventilated critically ill patients who exhibit diaphragm hibernation during IMV, to investigate inflammatory and metabolic factors and other clinical exposures associated with diaphragm hibernation, and to explore associations between diaphragm hibernation and weaning related and survival outcomes.

Study design:

Prospective, observational, longitudinal cohort study.

Study population:

Adult ICU patients receiving IMV, expected to remain mechanically ventilated for at least 72 hours.

Intervention (if applicable):

Not applicable. This is an observational study. Study specific procedures consist of repeated phrenic nerve magnetic stimulation and additional blood sampling.

Main study parameters/endpoints:

The primary study parameter is the proportion of participants exhibiting diaphragm hibernation during IMV. Diaphragm hibernation is defined as an increase in stimulated twitch tracheal pressure (Ptr,stim), a measure of diaphragm strength, of at least 10% relative to baseline (Day 0-1) at any follow up assessment (Day 2, 3, 5, or 7) obtained before extubation or death. Ptr,stim will be assessed repeatedly on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Participant burden is limited and mainly consists of repeated phrenic nerve magnetic stimulation during a ventilator delivered end expiratory occlusion and additional blood sampling of 9.5 mL per time point, up to a total of 47.5 mL across the study period. Magnetic stimulation is non-invasive and expected discomfort is transient. Rare transient physiological changes may occur and measurements are performed under continuous ICU monitoring and will be postponed or omitted if considered unsafe or interfering with clinical care. Direct benefit for participants is limited, but the study may provide clinically relevant knowledge on diaphragm hibernation and its driving factors. The research questions are specific to diaphragm physiology during IMV in critically ill patients, therefore the study is group related and cannot be performed in a different population.

Обзор исследования

Статус

Еще не набирают

Условия

Тип исследования

Наблюдательный

Регистрация (Оцененный)

112

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Jinyu Zhou, M.sc.
  • Номер телефона: 0031626194204
  • Электронная почта: jinyu.zhou@radboudumc.nl

Места учебы

  • Нидерланды
    • Gelderland
      • Nijmegen, Gelderland, Нидерланды, 6525 GA
        • Radboud University Medical Center (Radboudumc)
        • Контакт:

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

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

The study population consists of newly admitted adult ICU patients receiving invasive mechanical ventilation, in whom the first study assessment can be performed within 36 hours after initiation of IMV and who are expected to require IMV for at least 3 days.

Описание

Inclusion Criteria:

  • Age ≥ 18 years.
  • Receiving invasive mechanical ventilation at screening.
  • Expected to remain mechanically ventilated for ≥ 72 hours from enrolment.
  • The first study assessment can be performed within 36 hours after initiation of invasive mechanical ventilation.

Exclusion Criteria:

  • Pre-existing neuromuscular disease affecting the diaphragm (e.g. motor neuron disease, myasthenia gravis, advanced muscular dystrophy, high cervical spinal cord injury) or use of neuromuscular blocker.
  • Known phrenic nerve palsy or prior diaphragmatic paralysis.
  • Long-term home mechanical ventilation (invasive or non-invasive) prior to ICU admission.
  • Post-operative patients after planned diaphragm or phrenic nerve surgery.
  • Contraindications to phrenic nerve magnetic stimulation (e.g., unstable cervical spine injury, uncontrolled intracranial hypertension, metallic implants in stimulation area as per manufacturer guidance).
  • Pregnancy.
  • Participation in another interventional trial that explicitly prohibits co-enrolment or is expected to substantially influence diaphragm function (e.g. experimental neuromuscular blocking strategies), as decided by the principal investigator.

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

Когорты и вмешательства

Группа / когорта
Patients with expected > 3 days of invasive mechanical ventilation
Patients expected > 3 days of invasive mechanical ventilation will be included in this study. Blood sample and diaphragm strength will be assessed repeatedly, until 7 days after initiation of invasive mechanical ventilation, extubation or death.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Blood C reactive protein level
Временное ограничение: C reactive protein will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
C reactive protein will be assessed by blood sample.
C reactive protein will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood procalcitonin level
Временное ограничение: Procalcitonin will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Procalcitonin will be assessed by blood sample.
Procalcitonin will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood metabolic biomarkers level
Временное ограничение: Metabolic biomarkers will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Metabolic biomarkers will be assessed by blood sample using OLINK Target 96 panel.
Metabolic biomarkers will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood TNF-α level
Временное ограничение: TNF-α will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
TNF-α will be assessed by blood sample.
TNF-α will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood IL-10 level
Временное ограничение: IL-10 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
IL-10 will be assessed by blood sample.
IL-10 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood IL-8 level
Временное ограничение: IL-8 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
IL-8 will be assessed by blood sample.
IL-8 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood IL-6 level
Временное ограничение: IL-6 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
IL-6 will be assessed by blood sample.
IL-6 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood ferritin level
Временное ограничение: Ferritin will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Ferritin will be assessed by blood sample.
Ferritin will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Proportion of participants exhibiting diaphragm hibernation during invasive mechanical ventilation
Временное ограничение: Ptr,stim will be assessed repeatedly on Day 0 to 1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Diaphragm hibernation is defined as an increase in stimulated twitch tracheal pressure (Ptr,stim), a measure of diaphragm strength, of at least 10% relative to baseline (Day 0 to 1) at any follow up assessment (Day 2, 3, 5, or 7) obtained before extubation or death.
Ptr,stim will be assessed repeatedly on Day 0 to 1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Number of days from intubation to successful extubation
Временное ограничение: Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
Data about number of days from intubation to successful extubation will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
Number of days from first SBT to successful extubation
Временное ограничение: Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
Data about number of days from first SBT to successful extubation will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
Incidence of weaning failure
Временное ограничение: Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
Weaning failure is defined as SBT failure or reintubation within 48 hours. Data will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
ICU length of stay
Временное ограничение: Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Data about ICU length of stay will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Hospital length of stay
Временное ограничение: Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
Data about hospital length of stay will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
ICU mortality
Временное ограничение: Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Data about ICU mortality will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Hospital mortality
Временное ограничение: Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
Data about hospital mortality will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
Day 28 all-cause mortality
Временное ограничение: Collected from study inclusion until Day 28 or death, whichever occurs first
Data about day 28 all-cause mortality will be retrieved from electronic medical records.
Collected from study inclusion until Day 28 or death, whichever occurs first
ICU-free days through day 28
Временное ограничение: Collected from ICU discharge until Day 28 or death, whichever occurs first
Data about ICU-free days through day 28 will be retrieved from electronic medical records.
Collected from ICU discharge until Day 28 or death, whichever occurs first
Hospital-free days through day 28
Временное ограничение: Collected from hospital discharge until Day 28 or death, whichever occurs first
Data about hospital-free days through day 28 will be retrieved from electronic medical records.
Collected from hospital discharge until Day 28 or death, whichever occurs first
Time to ICU discharge alive through day 28
Временное ограничение: Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Data about time to ICU discharge alive through day 28 will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Time to hospital discharge alive through day 28
Временное ограничение: Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
Data about time to hospital discharge alive through day 28 will be retrieved from electronic medical records.
Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Radboud University Medical Center

Следователи

  • Главный следователь: Jonne Doorduin, PhD, Radboud University Medical Centre (Radboudumc)
  • Учебный стул: Leo Heunks, M.D., PhD, Radboud University Medical Centre (Radboudumc)

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 (Оцененный)

1 октября 2026 г.

Первичное завершение (Оцененный)

1 сентября 2028 г.

Завершение исследования (Оцененный)

1 декабря 2028 г.

Даты регистрации исследования

Первый отправленный

9 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

14 сентября 2026 г.

Первый опубликованный (Действительный)

15 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

15 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • NL-011458

Планирование данных отдельных участников (IPD)

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НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

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. .

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