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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02799940
Enrollment
29
Registered
2016-06-15
Start date
2016-08-31
Completion date
2019-05-19
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

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.

Interventions

None listed

Sponsors

Hospital Regional Rio Gallegos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 HospitalThe extent of oxygenation will be assessed by the PaO2/FiO2 ratio obtained the day of diagnosis of ARDS

Secondary

MeasureTime frameDescription
Correlation between the static pressure and the total CO evidenced by CTWithin the first 60 days (plus or minus 3 days) after admission to HospitalThe static pressure will be obtained over the first 24 hours after randomization
Correlation between the static compliance and the total CO evidenced by CTWithin the first 60 days (plus or minus 3 days) after admission to HospitalThe static compliance will be obtained over the first 24 hours after randomization
Correlation between oxygenation index and the total CO evidenced by CTWithin the first 60 days (plus or minus 3 days) after admission to HospitalThe oxygenation index will be obtained over the first 24 hours after randomization
Correlation between the driving pressure and the total CO as evidenced by CTWithin the first 60 days (plus or minus 3 days) after admission to HospitalThe driving pressure will be obtained over the first 24 hours after randomization
Correlation between ventilator free days and the total CO evidenced by CTWithin the first 60 days (plus or minus 3 days) after admission to Hospital
Independent variables associated with total COWithin the first 60 days (plus or minus 3 days) after admission to HospitalA 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 lung injury score (LIS) and the total CO evidenced by CTWithin the first 60 days (plus or minus 3 days) after admission to HospitalThe lung injury score (LIS) will be obtained over the first 24 hours after randomization

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026