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Abnormalities in Lung Computed Tomography and Physiological Alterations in Patients With Acute Respiratory Distress Syndrome

19 de mayo de 2019 actualizado por: Hospital Regional Rio Gallegos
The objective of the study is to determine the correlation between the physiological variables and the degree of consolidation in lung computed tomography in patients with acute respiratory distress syndrome

Descripción general del estudio

Estado

Terminado

Descripción detallada

Acute respiratory distress syndrome (ARDS) involves respiratory failure from different causes, but with a common pathologic manifestation in the form of inflammatory pulmonary edema. Histopathological examination of tissue obtained from patients with ARDS suggests that the pathology is heterogeneous and involves 3 phases: exudative, inflammatory, and fibroproliferative. Such alterations are associated with a decreased lung compliance leading to an increased pressure in the airways under mechanical ventilation (MV) that becomes more pronounced with increasing severity of ARDS, so that the consequent respiratory mechanics has thus been shown to be determinant of patient outcomes. In addition, computed tomography (CT) has revealed a heterogeneous pattern of lung injury, with areas of normal lung interspersed with morphologically altered regions, among which abnormalities the ground-glass opacification and consolidation are the most frequent. It has been performed quantitative assessments of ARDS by means of CT, thus enabling a correlation of such pathologic details with physiologic and clinical parameters as well as with patient outcomes. From the above, the investigators hypothesize that in patients with ARDS, a greater involvement in oxygenation and higher mechanical alterations will be correlated with a more advanced consolidation in the CT scan. Therefore, the primary objective of the study will be to determine the correlation between the extent of oxygenation (assessed by the PaO2/FiO2 ratio) and the degree of consolidation (total CO) in the CT scan. The secondary objectives will be: (1) to determine the correlation between the driving pressure and the total CO as evidenced by CT; (2) to determine the correlation between the static pressure and the total CO; (3) to determine the correlation between the static compliance and the total CO; (4) to determine the correlation between oxygenation index and the total CO; (5) to determine the correlation between the lung injury score (LIS) and the total CO; (6) to determine the correlation between ventilator free days and the total CO; (7) to determine the independent variables associated with total CO; (8) to determine differences in the CT with respect to the total lung-disease score [total CO plus total value of ground-glass opacification (total GC)] between survivors and nonsurvivors.

Tipo de estudio

De observación

Inscripción (Actual)

29

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Santa Cruz
      • Rio Gallegos, Santa Cruz, Argentina, 9400
        • Hospital Regional Rio Gallegos

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

15 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Patients 15 years of age or older admitted in the intensive care unit (ICU) of the Rio Gallegos Regional Hospital who have been receiving MV and have been defined as with ARDS according to the Berlin definition.

Descripción

Inclusion Criteria:

  • Patients 15 years of age or older who have been receiving MV and have been defined as with ARDS according to the Berlin definition

Exclusion Criteria:

Patients with chronic pulmonary disease, with an expected duration of MV shorter than 48 h, or with a high risk of death within 3 months for reasons other than ARDS as well as patients having made the decision to withhold life-sustaining treatment along with those exhibiting clinical instability that could not be moved to the radiology department in order to perform CT scans.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Computed tomography in acute respiratory distress syndrome
The lung on computed tomography (CT) in patients with acute respiratory distress syndrome (ARDS) has revealed a heterogeneous pattern of lung injury, with areas of normal lung interspersed with altered regions: ground-glass opacification and consolidation among the most frequent. It has been performed quantitative assessments of ARDS by means of CT, thus enabling a correlation of such pathologic details with physiologic, clinical parameters and with patient outcomes. Therefore, the primary objective of the study is to determine the correlation between the extent of oxygenation (PaO2/FiO2) and the degree of consolidation (total CO) in the CT. The secondary objectives are to determine: the correlation between the driving pressure, ventilator variables and the total CO; the independent variables associated with total CO; differences in the CT with respect to the total lung-disease score (total CO plus total value of ground-glass opacification) between survivors and nonsurvivors.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan.
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
The extent of oxygenation will be assessed by the PaO2/FiO2 ratio obtained the day of diagnosis of ARDS
Within the first 60 days (plus or minus 3 days) after admission to Hospital

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation between the driving pressure and the total CO as evidenced by CT
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
The driving pressure will be obtained over the first 24 hours after randomization
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Correlation between the static pressure and the total CO evidenced by CT
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
The static pressure will be obtained over the first 24 hours after randomization
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Correlation between the static compliance and the total CO evidenced by CT
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
The static compliance will be obtained over the first 24 hours after randomization
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Correlation between oxygenation index and the total CO evidenced by CT
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
The oxygenation index will be obtained over the first 24 hours after randomization
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Correlation between the lung injury score (LIS) and the total CO evidenced by CT
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
The lung injury score (LIS) will be obtained over the first 24 hours after randomization
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Correlation between ventilator free days and the total CO evidenced by CT
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Independent variables associated with total CO
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
A multivariate logistic-regression model will be used to independent assess variables that showed correlation with total CO. The investigators also will be introduced in the model the potential confounders: age, gender, APACHE-II score and SOFA score.
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Differences in the CT with respect to the total lung-disease score [total CO plus total value of ground-glass opacification (total GC)] between survivors and nonsurvivors.
Periodo de tiempo: Within the first 60 days (plus or minus 3 days) after admission to Hospital
Within the first 60 days (plus or minus 3 days) after admission to Hospital

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Roberto Santa Cruz, Doctor, Hospital Regional Rio Gallegos

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2016

Finalización primaria (Actual)

19 de mayo de 2019

Finalización del estudio (Actual)

19 de mayo de 2019

Fechas de registro del estudio

Enviado por primera vez

2 de junio de 2016

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2016

Publicado por primera vez (Estimar)

15 de junio de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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