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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Pays-Bas, 1081HV
- VU University Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Abdominal expiratory muscle thickness
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diaphragm muscle thickness
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Leo M Heunks, Amsterdam UMC, location VUmc
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EMFIC
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .