- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04333186
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Noord-Holland
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Amsterdam, Noord-Holland, Alankomaat, 1081HV
- VU University Medical Center
-
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Abdominal expiratory muscle thickness
Aikaikkuna: 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
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Diaphragm muscle thickness
Aikaikkuna: 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
|
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
|
|
Inflammatory markers
Aikaikkuna: Within 24 hours after inclusion
|
Inflammatory markers (TNF-alpha, IL-6, IL-10) at inclusion (measured from blood sample using ELISA technique).
|
Within 24 hours after inclusion
|
|
Applied driving pressure
Aikaikkuna: 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
|
Appplied driving pressuye defined as peak pressure minus total postive end expiratory pressure, and measured 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
|
|
Tidal volume
Aikaikkuna: 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
|
|
Positive end expiratory pressure
Aikaikkuna: 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
|
|
Extubation failure
Aikaikkuna: 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
|
Reintubated after extubation
|
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
|
|
Readmission to ICU
Aikaikkuna: 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
|
Readmitted to ICU after the ICU discharge
|
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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Leo M Heunks, Amsterdam UMC, location VUmc
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- EMFIC
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
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