Clinical trial NCT02799940: Abnormalities in Lung Computed Tomography and Physiological Alterations in Patients With Acute Respiratory Distress Syndrome
Official title: Abnormalities in Lung Computed Tomography and Physiological Alterations in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Lead sponsor: Hospital Regional Rio Gallegos
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 29
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan.
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
Secondary outcomes:
measure: Correlation between the driving pressure and the total CO as evidenced by CT
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
measure: Correlation between the static pressure and the total CO evidenced by CT
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
measure: Correlation between the static compliance and the total CO evidenced by CT
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
measure: Correlation between oxygenation index and the total CO evidenced by CT
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
measure: Correlation between the lung injury score (LIS) and the total CO evidenced by CT
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
measure: Correlation between ventilator free days and the total CO evidenced by CT
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
measure: Independent variables associated with total CO
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
measure: 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.
timeFrame: Within the first 60 days (plus or minus 3 days) after admission to Hospital
Other outcomes:
Locations:
city: Rio Gallegos
country: Argentina
facility: Hospital Regional Rio Gallegos
state: Santa Cruz
Study officials:
affiliation: Hospital Regional Rio Gallegos
name: Roberto Santa Cruz, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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