- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02799940
Abnormalities in Lung Computed Tomography and Physiological Alterations in Patients With Acute Respiratory Distress Syndrome
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Santa Cruz
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Rio Gallegos, Santa Cruz, Argentína, 9400
- Hospital Regional Rio Gallegos
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
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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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan.
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Correlation between the driving pressure and the total CO as evidenced by CT
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Roberto Santa Cruz, Doctor, Hospital Regional Rio Gallegos
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- MJL001
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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Klinikai vizsgálatok a Légzési distressz szindróma, felnőtt
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Chiesi Farmaceutici S.p.A.MegszűntRespiratory Distress Syndrome (RDS)Egyesült Államok
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Tel-Aviv Sourasky Medical CenterIsmeretlenVérmérgezés | Akut tüdősérülés (ALI) | Acure Respiratory Distress Syndrome (ARDS)Izrael
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NICHD Neonatal Research NetworkNational Center for Research Resources (NCRR)MegszűntTüdőgyulladás | Vérmérgezés | Hipertónia, tüdőgyulladás | Csecsemő, a terhességi korhoz képest kicsi | Csecsemő, Koraszülött | Csecsemő, alacsony születési súlyú | Csecsemő, Újszülött | Respiratory Distress Syndrome (RDS)Egyesült Államok