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- Ensayo clínico NCT03094299
Diaphragm Ultrasound in Weaning From Mechanical Ventilation
The Efficacy of Ultrasound Assessment of Diaphragmatic Function in Guiding Weaning From Mechanical Ventilation in Critically Ill Patients With Abdominal Sepsis
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Difficult weaning from mechanical ventilation (MV) is a common problem in critically ill patients. Many parameters have been developed to aid weaning from MV such as P/F ratio (PO2/FiO2) and rapid shallow breathing index (respiratory rate/tidal volume); however, sensitivity and specificity for most variables are still variable in literature.
Diaphragmatic dysfunction is a common cause of weaning failure (2) however most of the traditional methods used for evaluation of diaphragmatic function (fluoroscopy, trans-diaphragmatic pressure measurement) are invasive and not available.
Ultrasound assessment of diaphragmatic function has been developed recently providing an easy and safe method for evaluation of diaphragmatic excursion and thickening. In this study we will evaluate the ability of the diaphragmatic function to predict weaning success in patients with abdominal sepsis.
After weaning, patients will be divided into two groups; group of successful weaning (group S) and group with failed weaning (group F) both groups will be compared as regards all clinical, laboratory, and ultrasonographic parameters recorded before weaning, further analysis will be done for patients with repeated trials of weaning (more than one trial or more than one week MV) and those with simple weaning (first time for weaning).
A 7-10 Mega Hertz linear ultrasound probe (Mindray machine) set to B mode, the diaphragm will be visualized by placing the transducer perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and the midaxillary lines, to observe the zone of apposition of the muscle 0.5 to 2 cm below the costophrenic sinus.
The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line. Then, the diaphragmatic fraction thickening (DTF) will be calculated as percentage Diaphragmatic movement will be measured in all patients with a 3.5 Mega Hertz US probe placed over one of the lower intercostal spaces in the right anterior axillary line for the right diaphragm and the left midaxillary line for the left diaphragm.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Cairo University
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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:
- Critically ill patients with abdominal sepsis with history of MV for more than 48 hours
Exclusion Criteria:
- Age < 18 years and surgical dressings over the right lower rib cage which would preclude ultrasound examination will be excluded. Also, patients with chest trauma, thoracotomy, diaphragmatic paralysis, diaphragmatic dysfunction, diaphragmatic injury, diaphragmatic surgery and patients with neuromuscular diseases
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 |
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Diaphragmatic thickening fraction
Periodo de tiempo: five minutes before spontaneous breathing trial
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(calculated as maximum thickness - minimum thickness / maximum thickness)
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five minutes before spontaneous breathing trial
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Diaphragmatic excursion
Periodo de tiempo: five minutes before spontaneous breathing trial and five minutes before patient extubation
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(measured in millimeters)
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five minutes before spontaneous breathing trial and five minutes before patient extubation
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Rapid shallow breathing index (RSBI)
Periodo de tiempo: five minutes before spontaneous breathing trial
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Respiratory rate/tidal volume in litres
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five minutes before spontaneous breathing trial
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Arterial blood gases
Periodo de tiempo: five minutes before spontaneous breathing trial and five minutes before patient extubation
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Partial oxygen pressure and Partial carbon dioxide pressure
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five minutes before spontaneous breathing trial and five minutes before patient extubation
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Number of weaning trials
Periodo de tiempo: during the last 7 days
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number of weaning trials before this trial
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during the last 7 days
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Heart rate
Periodo de tiempo: five minutes before spontaneous breathing trial and five minutes before patient extubation
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the patient heart rate measured as beat.minute
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five minutes before spontaneous breathing trial and five minutes before patient extubation
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Arterial blood pressure
Periodo de tiempo: five minutes before spontaneous breathing trial and five minutes before patient extubation
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systolic and diastolic blood pressure measured in mmHg
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five minutes before spontaneous breathing trial and five minutes before patient extubation
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
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Finalización del estudio (Actual)
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Enviado por primera vez
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Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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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
- N-16-2017
Plan de datos de participantes individuales (IPD)
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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.
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Ensayos clínicos sobre Sepsis Abdominal
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University of CalgaryAlberta Health servicesReclutamientoSepsis Abdominal | Infección AbdominalCanadá
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Milton S. Hershey Medical CenterRetiradoSepticemia | Shock séptico | Disfunción de múltiples órganos | Sepsis intraabdominal
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Jinling Hospital, ChinaTerminadoFístula del sistema digestivo | Apendicitis | Absceso Abdominal | Pancreatitis | Sepsis severaPorcelana
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University Hospital, GenevaTerminadoPeritonitis | Sepsis Abdominal | Perforación de colonSuiza
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Assiut UniversityTerminadoPeritonitis sépticaEgipto
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Universidad Autonoma de San Luis PotosíDesconocido
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Unity Health TorontoReclutamientoPeritonitis | Absceso Abdominal | Lesiones Abdominales | Trauma abdominal | Sepsis Abdominal | Aneurisma Abdominal | Síndrome Compartimental Abdominal | Infección AbdominalCanadá
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Tianjin Medical University Cancer Institute and...Zhejiang Hisun Pharmaceutical Co. Ltd.DesconocidoInfección AbdominalPorcelana
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Sociedade Brasileira de Atendimento Integrado ao...DesconocidoTrauma abdominal | Sepsis Abdominal | Síndrome Compartimental Abdominal
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Aristotle University Of ThessalonikiTerminado