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

19 maja 2019 zaktualizowane przez: Hospital Regional Rio Gallegos
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

Przegląd badań

Status

Zakończony

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

29

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Santa Cruz
      • Rio Gallegos, Santa Cruz, Argentyna, 9400
        • Hospital Regional Rio Gallegos

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

15 lat i starsze (Dziecko, Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Correlation between the extent of oxygenation and the degree of consolidation (total CO) in the CT scan.
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Correlation between the driving pressure and the total CO as evidenced by CT
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
Within the first 60 days (plus or minus 3 days) after admission to Hospital
Independent variables associated with total CO
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
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.
Ramy czasowe: Within the first 60 days (plus or minus 3 days) after admission to Hospital
Within the first 60 days (plus or minus 3 days) after admission to Hospital

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Roberto Santa Cruz, Doctor, Hospital Regional Rio Gallegos

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 sierpnia 2016

Zakończenie podstawowe (Rzeczywisty)

19 maja 2019

Ukończenie studiów (Rzeczywisty)

19 maja 2019

Daty rejestracji na studia

Pierwszy przesłany

2 czerwca 2016

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 czerwca 2016

Pierwszy wysłany (Oszacować)

15 czerwca 2016

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 maja 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 maja 2019

Ostatnia weryfikacja

1 maja 2019

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

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