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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Noord-Holland
-
Amsterdam, Noord-Holland, Países Bajos, 1081HV
- VU University Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Abdominal expiratory muscle thickness
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diaphragm muscle thickness
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Leo M Heunks, Amsterdam UMC, location VUmc
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EMFIC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .