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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

Brief Summary: 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

Detailed Summary: 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 i
Sponsor: Hospital Regional Rio Gallegos

Current Primary Outcome: Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan. [ Time Frame: Within the first 60 days (plus or minus 3 days) after admission to Hospital ]

Original Primary Outcome: Correlation between the extent of oxygenation (assessed by the PaO2/FiO2 ratio) and the degree of consolidation (total CO) in the CT scan. [ Time Frame: Within the first 60 days (plus or minus 3 days) after admission to Hospital ]

Current Secondary Outcome:

• Correlation between the driving pressure and the total CO as evidenced by CT [ Time Frame: 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
• Correlation between the static pressure and the total CO evidenced by CT [ Time Frame: 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
• Correlation between the static compliance and the total CO evidenced by CT [ Time Frame: 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
• Correlation between oxygenation index and the total CO evidenced by CT [ Time Frame: 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
• Correlation between the lung injury score (LIS) and the total CO evidenced by CT [ Time Frame: 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
• Correlation between ventilator free days and the total CO evidenced by CT [ Time Frame: Within the first 60 days (plus or minus 3 days) after admission to Hospital ]
• Independent variables associated with total CO [ Time Frame: 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.
• 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. [ Time Frame: Within the first 60 days (plus or minus 3 days) after admission to Hospital ]

Original Secondary Outcome:

• Correlation between the driving pressure and the total CO as evidenced by CT [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within the first 60 days (plus or minus 3 days) after admission to Hospital ]
• Independent variables associated with total CO [ Time Frame: Within the first 60 days (plus or minus 3 days) after admission to Hospital ]
  A multivariate logistic-regression model will be used to independently assess variables found to be significantly associated with total CO adjusting for potential confounders. The independent variables tested as predictors included: PaO2/FiO2 ratio, ventilator variables: static pressure, static compliance, driving pressure and lung-injury score (LIS) averaged over the first 24 hours after randomization. The following potential confounders will be considered: age, sex, the APACHE-II score, the LIS score, and the SOFA score.
• 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. [ Time Frame: Within the first 60 days (plus or minus 3 days) after admission to Hospital ]

Dates:
Date Received: June 2, 2016
Date Started: August 2016
Date Completion: June 2019
Last Updated: September 1, 2016
Last Verified: June 2016