Abnormalities in Lung Computed Tomography and Physiological Alterations in Patients With Acute Respiratory Distress Syndrome
- Conditions
- Respiratory Distress Syndrome, Adult
- Registration Number
- NCT02799940
- Lead Sponsor
- Hospital Regional Rio Gallegos
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- Patients 15 years of age or older who have been receiving MV and have been defined as with ARDS according to the Berlin definition
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan. 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
- Secondary Outcome Measures
Name Time Method Correlation between the lung injury score (LIS) and the total CO evidenced by CT 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 the static compliance and the total CO evidenced by CT 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
Independent variables associated with total CO 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. Within the first 60 days (plus or minus 3 days) after admission to Hospital Correlation between the driving pressure and the total CO as evidenced by CT 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 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 ventilator free days and the total CO evidenced by CT 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 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
Trial Locations
- Locations (1)
Hospital Regional Rio Gallegos
🇦🇷Rio Gallegos, Santa Cruz, Argentina