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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the driving pressure and the total CO as evidenced by CT | 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 |
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Inclusion Criteria:
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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Santa Cruz, Doctor | Hospital Regional Rio Gallegos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Rio Gallegos | RÃo Gallegos | Santa Cruz Province | 9400 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12163791 | Background | Schoenfeld DA, Bernard GR; ARDS Network. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med. 2002 Aug;30(8):1772-7. doi: 10.1097/00003246-200208000-00016. | |
| 10793167 | Result | Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. doi: 10.1056/NEJM200005043421806. No abstract available. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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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 | 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 | 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 | 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 | Within the first 60 days (plus or minus 3 days) after admission to Hospital |
| Independent variables associated with total CO | 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. | Within the first 60 days (plus or minus 3 days) after admission to Hospital |
| 22797452 | Result | ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. |
| 9449727 | Result | Amato MB, Barbas CS, Medeiros DM, Magaldi RB, Schettino GP, Lorenzi-Filho G, Kairalla RA, Deheinzelin D, Munoz C, Oliveira R, Takagaki TY, Carvalho CR. Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome. N Engl J Med. 1998 Feb 5;338(6):347-54. doi: 10.1056/NEJM199802053380602. |
| 10793162 | Result | Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801. |
| 3701964 | Result | Maunder RJ, Shuman WP, McHugh JW, Marglin SI, Butler J. Preservation of normal lung regions in the adult respiratory distress syndrome. Analysis by computed tomography. JAMA. 1986 May 9;255(18):2463-5. |
| 9885583 | Result | Desai SR, Wells AU, Rubens MB, Evans TW, Hansell DM. Acute respiratory distress syndrome: CT abnormalities at long-term follow-up. Radiology. 1999 Jan;210(1):29-35. doi: 10.1148/radiology.210.1.r99ja2629. |
| 3057937 | Result | Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, Fumagalli R, Marcolin R, Mascheroni D, et al. Relationships between lung computed tomographic density, gas exchange, and PEEP in acute respiratory failure. Anesthesiology. 1988 Dec;69(6):824-32. doi: 10.1097/00000542-198812000-00005. |
| 24722949 | Result | Burnham EL, Hyzy RC, Paine R 3rd, Kelly AM, Quint LE, Lynch D, Curran-Everett D, Moss M, Standiford TJ. Detection of fibroproliferation by chest high-resolution CT scan in resolving ARDS. Chest. 2014 Nov;146(5):1196-1204. doi: 10.1378/chest.13-2708. |
| 7988207 | Result | Owens CM, Evans TW, Keogh BF, Hansell DM. Computed tomography in established adult respiratory distress syndrome. Correlation with lung injury score. Chest. 1994 Dec;106(6):1815-21. doi: 10.1378/chest.106.6.1815. |
| 3202424 | Result | Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available. |
| 10551239 | Result | Goodman LR, Fumagalli R, Tagliabue P, Tagliabue M, Ferrario M, Gattinoni L, Pesenti A. Adult respiratory distress syndrome due to pulmonary and extrapulmonary causes: CT, clinical, and functional correlations. Radiology. 1999 Nov;213(2):545-52. doi: 10.1148/radiology.213.2.r99nv42545. |
| 25693014 | Result | Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639. |
| 3928249 | Result | Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29. |
| 9824069 | Result | Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016. |