Expiratory Muscle Function in Critically Ill Ventilated Patients (EMFIC)
Inspiratory muscle weakness develops rapidly in ventilated critically ill patients and is associated with adverse outcome, including prolonged duration of mechanical ventilation and mortality. Surprisingly, the effects of critical illness on expiratory muscle function have not been studied.
The main expiratory muscles are the abdominal wall muscles, including the external oblique (EO), internal oblique (IO) and transversus abdominis muscles (TRA). These muscles are activated when respiratory drive or load increases, which can be during e.g. exercise, diaphragm fatigue, increased airway resistance, or positive airway pressure ventilation. The abdominal wall muscles are also critical for protective reflexes, such as coughing. Reduced abdominal muscles strength may lead to decreased cough function and thus inadequate airway clearance. This will lead to secretion pooling in the lower airways, atelectasis, and ventilator associated pneumonia (VAP). Studies have shown that decreased cough function is a risk for weaning failure and (re)hospitalization for respiratory complications. Further, high mortality was found in patients with low peak expiratory flow.
Considering the importance of a proper expiratory muscle function in critically ill patients, it is surprising that the prevalence, causes, and functional impact of changes in expiratory abdominal muscles thickness during mechanical ventilation (MV) for critically ill patients are still unknown.
Ultrasound is increasingly used in the ICU for the visualization of respiratory muscles. In a recent pilot study the investigators confirmed the feasibility and reliability of using of ultrasound to evaluate both diaphragm and expiratory abdominal muscle thickness in ventilated critically ill patients (manuscript in preparation). Accordingly, the primary aim of the present study is to evaluate the evolution of abdominal expiratory muscle thickness during MV in adult critically ill patients, using ultrasound data.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Noord-Holland
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Amsterdam, Noord-Holland, Holandia, 1081HV
- VU University Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Age > 18 years
- Invasive mechanical ventilation < 48 hours
- Expected duration of mechanical ventilation > 72 hours
Exclusion Criteria:
- Past medical history of neuromuscular disorders
- Mechanical ventilation > 48 hours within the current hospital admission
- Pregnant women
- Open abdominal wounds at proposed location of the ultrasound probe, due to recent abdominal surgery
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Abdominal expiratory muscle thickness
Ramy czasowe: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
Thickness of the abdominal expiratory muscles measured in millimeters
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From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Diaphragm muscle thickness
Ramy czasowe: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
Thickness of the diaphragm muscle measured in millimeters
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From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
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Inflammatory markers
Ramy czasowe: Within 24 hours after inclusion
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Inflammatory markers (TNF-alpha, IL-6, IL-10) at inclusion (measured from blood sample using ELISA technique).
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Within 24 hours after inclusion
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Applied driving pressure
Ramy czasowe: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
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Appplied driving pressuye defined as peak pressure minus total postive end expiratory pressure, and measured in centimetre of water
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From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
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Tidal volume
Ramy czasowe: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
Tidal volume measured in liters
|
From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
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Positive end expiratory pressure
Ramy czasowe: From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
Postive end expiratory pressure measure in centimetre of water
|
From the date of inclusion until the date of first extubation or date of death from any cause, whichever came first, assessed up to 6 weeks
|
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Extubation failure
Ramy czasowe: From the date of extubation to the date of reintubation, or the date of death from any cause, or the date of ICU discharge, whichever came first, assessed up to 6 weeks
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Reintubated after extubation
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From the date of extubation to the date of reintubation, or the date of death from any cause, or the date of ICU discharge, whichever came first, assessed up to 6 weeks
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Readmission to ICU
Ramy czasowe: From the date of ICU diascharge to the date of death from any cause, or the date of hospital discharge, whichever came first, assessed up to 6 weeks
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Readmitted to ICU after the ICU discharge
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From the date of ICU diascharge to the date of death from any cause, or the date of hospital discharge, whichever came first, assessed up to 6 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Leo M Heunks, Amsterdam UMC, location VUmc
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EMFIC
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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