- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07834970
Mechanical Power During Pressure Controlled Versus Volume-Controlled Ventilation in Acute Respiratory Failure (MP-PCV-VCV)
Mechanical Power During Pressure-Controlled Versus Volume Controlled Mechanical Ventilation in Patients With Acute Respiratory Failure
This prospective observational cohort study aims to compare mechanical power between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) in critically ill adult patients receiving invasive mechanical ventilation. Mechanical power will be assessed at different time points during the first 24 hours after intubation, with the primary comparison performed at 24 hours. The study will also evaluate the association between mechanical power and clinical outcomes, including ICU mortality, hospital mortality, successful weaning, duration of mechanical ventilation, and length of ICU and hospital stay.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Mechanical ventilation is a life-saving intervention for critically ill patients with acute respiratory failure. However, mechanical ventilation can also contribute to ventilator-induced lung injury when excessive energy is delivered to the respiratory system. Mechanical power, which represents the energy transferred from the ventilator to the respiratory system per unit of time, has emerged as a potentially important parameter for assessing the intensity of mechanical ventilation.
The mode of ventilation may influence mechanical power through changes in airway pressure, tidal volume, respiratory rate, and inspiratory flow. Pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) are commonly used modes of invasive mechanical ventilation, but their effects on mechanical power in critically ill patients may differ.
Therefore, this prospective observational cohort study aims to compare mechanical power between PCV and VCV in critically ill adult patients receiving invasive mechanical ventilation and to evaluate the relationship between mechanical power and relevant clinical outcomes.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sahar Ahmed Okily, Master degree of chest disease
- Número de teléfono: 01094504484 0201094504484
- Correo electrónico: sara3hmed2012@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Hend Mohamed Sayed, Lecturer
- Número de teléfono: 0201098988712
- Correo electrónico: Hendmohamed@aun.edu.eg
Ubicaciones de estudio
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Asyut, Egipto
- Assuit 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
Adult patients aged >18 years with acute respiratory failure requiring invasive mechanical ventilation and admitted to the Respiratory Intensive Care Unit at Assiut University Hospitals will be enrolled. Eligible patients receiving either pressure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) will be prospectively followed during their ICU and hospital stay.
Descripción
Inclusion Criteria:
- Adult patients aged >18 years.
- Patients with acute respiratory failure who are receiving invasive mechanical ventilation.
Exclusion Criteria:
- Patients whose condition requires shifting between VCV and PCV after enrollment.
- Patients with neurological, neuromuscular, or muscular disorders.
- Neurological disorders, e.g., stroke, multiple sclerosis, Parkinsonism, and Guillain-Barré syndrome.
- Neuromuscular junction disorders, e.g., myasthenia gravis.
- Muscular disorders, e.g., polymyositis and Duchenne muscular dystrophy.
- Chest wall abnormalities, e.g., kyphoscoliosis, scoliosis, and pectus excavatum.
- Tracheostomized patients.
- Patients with raised intra-abdominal pressure (IAP ≥12 mmHg), as estimated by transvesical manometry e.g., massive ascites, bowel obstruction, and postoperative abdominal surgery.
- Patients with documented chronic type 2 respiratory failure, characterized by an elevated partial pressure of carbon dioxide (PaCO₂ >45 mmHg), low partial pressure of oxygen (PaO₂), and chronically elevated bicarbonate (HCO₃-) reflecting renal compensation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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93 patients in Pressure controlled ventilation
93 patients in Volume controlled ventilation |
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93 patients in PCV
93 patients in Volume controlled ventilation |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mechanical power
Periodo de tiempo: 24 hours after intubation
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Mechanical power will be measured and compared between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) at 24 hours after intubation. |
24 hours after intubation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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mechanical power and ICU mortality, hospital mortality, time to death.
Periodo de tiempo: From hospital admission until 30 days after hospital admission.
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Correlation between mechanical power and ICU mortality, hospital mortality, time to death .
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From hospital admission until 30 days after hospital admission.
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Mechanical power over time
Periodo de tiempo: At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
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Changes in mechanical power over time following initiation of invasive mechanical ventilation. |
At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
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Successful weaning from mechanical ventilation
Periodo de tiempo: From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
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Correlation between Mechanical power and successful weaning from mechanical ventilation .Successful weaning is defined as successful extubation without the need for re-intubation or noninvasive ventilation (NIV) within the following 48 hours. |
From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Olfat Mostafa El shinawy, Professor, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
- Director de estudio: Sara Mohamed Hashem, Lecteurer, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- AUN-CH-MP-001
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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