- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02799940
Abnormalities in Lung Computed Tomography and Physiological Alterations in Patients With Acute Respiratory Distress Syndrome
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Santa Cruz
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Rio Gallegos, Santa Cruz, Argentinien, 9400
- Hospital Regional Rio Gallegos
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan.
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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The extent of oxygenation will be assessed by the PaO2/FiO2 ratio obtained the day of diagnosis of ARDS
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Correlation between the driving pressure and the total CO as evidenced by CT
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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The driving pressure will be obtained over the first 24 hours after randomization
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Correlation between the static pressure and the total CO evidenced by CT
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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The static pressure will be obtained over the first 24 hours after randomization
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Correlation between the static compliance and the total CO evidenced by CT
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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The static compliance will be obtained over the first 24 hours after randomization
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Correlation between oxygenation index and the total CO evidenced by CT
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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The oxygenation index will be obtained over the first 24 hours after randomization
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Correlation between the lung injury score (LIS) and the total CO evidenced by CT
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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The lung injury score (LIS) will be obtained over the first 24 hours after randomization
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Correlation between ventilator free days and the total CO evidenced by CT
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Independent variables associated with total CO
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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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.
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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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.
Zeitfenster: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Within the first 60 days (plus or minus 3 days) after admission to Hospital
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Roberto Santa Cruz, Doctor, Hospital Regional Rio Gallegos
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Am Rev Respir Dis 1989 Apr;139(4):1065.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MJL001
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