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

14 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

112

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Holandia
    • Gelderland
      • Nijmegen, Gelderland, Holandia, 6525 GA
        • Radboud University Medical Center (Radboudumc)
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Blood C reactive protein level
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants exhibiting diaphragm hibernation during invasive mechanical ventilation
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Radboud University Medical Center

Śledczy

  • Główny śledczy: Jonne Doorduin, PhD, Radboud University Medical Centre (Radboudumc)
  • Krzesło do nauki: Leo Heunks, M.D., PhD, Radboud University Medical Centre (Radboudumc)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 września 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

9 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 września 2026

Pierwszy wysłany (Rzeczywisty)

15 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

15 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NL-011458

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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