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Идёт набор NCT05947422

CT Quantitative Assessment of Interstitial Lung Disease

Наблюдательное Interstitial Lung Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High resolution CT Chest, Spirometry.
Кому может быть актуально
Состояния в реестре: Interstitial Lung Disease. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

CT Quantitative Assessment of Interstitial Lung Disease Using Visual Score and Lung Densitometry Methods and Its Correlation With Pulmonary Function Tests

Обзор

Interstitial lung disease (ILD) refers to a broad category of heterogeneous lung diseases with different etiologies and features characterized by inflammation and fibrosis of the lung parenchyma and manifested as exertional dyspnea, interstitial patterns on high resolution computed tomography (HRCT), and abnormal pulmonary function tests (PFTs) The aim of this study is to investigate is there any correlation between changes seen in the lung parenchyma by HRCT and the pulmonary functions of the patients.

Подробное описание

This study will utilize a cross-sectional prospective study design in a single institution to investigate the correlation between CT chest findings including lung densitometry and pulmonary function test results in patients with ILD.

The study population will consist of consecutive patients diagnosed with ILD recruited from the pulmonary clinic or inpatient service.

High resolution CT chest and pulmonary function tests are routine diagnostic tests used for diagnosis of interstitial lung disease .

both tests are non invasive for the patient and will be acquired for all patients and then their results will be correlated.

Вмешательства

  • Диагностический тест High resolution CT Chest
    CT chest in our institution will be done with standard high resolution protocol . No I.V contrast will be given. Scans will be obtained during full inspiration in supine position from the thoracic inlet to the level of the diaphragm. Patients with CT chest performed outside our institution will be reviewed in DICOM format and assessed for its compatibility to be integrated into the computer-based analysis software.
  • Диагностический тест Spirometry
    Spirometry will be performed using standard techniques according to ATS-ERS criteria 2019 . Spirometry device (Zan 300, NSPIRE HEALTH GMBH Co.) will be used. Percentage predicted values (%pred) will be calculated based on reference values for healthy adults. All patients will be required to undergo spirometry in a reproducible way, and the best values will be reported. Spirometry should meet international acceptability and repeatability standards

Первичные конечные точки

  • CT visual Warrick score (measured by points) [Срок оценки: baseline]
  • Total lung volume, Volume of lung occupied by low attenuation areas, Volume of lung occupied by high attenuation areas, Volume of normal lung areas and volume of consolidation areas [Срок оценки: baseline]
  • Percentage of the lung occupied by low attenuation areas, percentage of normal lung, percentage of the lung occupied by high attenuation areas and percentage of consolidation areas. [Срок оценки: baseline]
  • Mean lung density of each lung, both lungs and every lobe in Hounsfield unit (HU) [Срок оценки: baseline]
  • Forced vital capacity (FVC) [Срок оценки: baseline]
  • Forced expiratory volume in 1 second (FEV1) [Срок оценки: baseline]
  • FEV1/FVC ratio [Срок оценки: baseline]
  • O2 saturation [Срок оценки: baseline]

Критерии участия

Критерии включения

  • Diagnosis of ILD (based on clinical, radiological, and pulmonary function criteria +/- histopathological criteria).
  • Availability of CT chest DICOM images and pulmonary function test results (within a 2-weeks period from each other).

Критерии исключения

  • Pregnancy
  • Pulmonary edema.
  • Primary pulmonary hypertension;
  • Chronic obstructive pulmonary disease
  • Congestive heart failure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Египет · 1 центр
  • Assiut University Hospital — Asyut

Идентификаторы

NCT: NCT05947422 · ILD-CT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗