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

Respiratory Distress Syndrome, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799940
• Other study ID #: MJL001
• Status: Completed
• Start date: August 2016
• Est. completion date: May 19, 2019

Study information

• Verified date: May 2019
• Source: Hospital Regional Rio Gallegos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 19, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
Argentina	Hospital Regional Rio Gallegos	Rio Gallegos	Santa Cruz

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional Rio Gallegos

Country where clinical trial is conducted

Argentina, 

References & Publications (15)

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 sy — View Citation

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 — View Citation

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):74 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 De — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Am Rev Respir Dis 1989 Apr;139(4):1065. — View Citation

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. — View Citation

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. — View Citation

Vincent JL, de Mendonça 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. Workin — View Citation

Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Correlation between the static pressure and the total CO evidenced by CT	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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