The Use of Electrical Impedance Tomography (EIT) in Pulmonary Diseases

Обзор

The study titled "The Use of Electrical Impedance Tomography (EIT) in Pulmonary Diseases" investigates the impact of using EIT as a non-invasive method to monitor the distribution of pulmonary ventilation and its relationship to standard spirometry in patients with various lung diseases. The main aim of this study is to investigate new approaches to the assessment of lung status and diagnosis of lung diseases. Unlike spirometry, which has long been a well-known and important diagnostic tool in pulmonary medicine, and which provides valuable information about the volume and flow of inspired and expired air, EIT provides spatial information about the distribution of ventilation in real time and without the need for active patient cooperation. Research and practice have shown that spirometry is problematic in specific groups of patients, such as patients with tracheostomy or facial palsy. The technology should also enable detection of the disease in its early stages, when treatment is most effective. 300 participants in the experimental group and 100 participants in the control group will receive spirometry and electrical impedance tomography independent examination. The primary endpoint of the study is to investigate the potential of EIT in respiratory medicine, specifically identifying the relationship between EIT and traditional spirometry. This effort is motivated by the need for novel noninvasive methods for the diagnosis and monitoring of respiratory diseases, especially in patients unable to undergo conventional spirometry, or in case of interventions requiring real-time feedback. The purpose of the research project in relation to these objectives is to bring new possibilities in the field of diagnosis and monitoring of lung diseases through EIT, which could lead to significant improvements in patient care. Demographic and anthropometric data, including age, sex, body height, body weight, body mass index (BMI), chest circumference, and smoking history will be collected in all participants. These parameters will be used as covariates in the analysis to assess their impact on EIT-derived indicators and to improve normalization of EIT signals. Additionally, the study aims to develop and validate a machine learning model, particularly a deep neural network, capable of predicting standard spirometric parameters (e.g., FEV1, FVC, PEF) based solely on EIT signals. This could allow for an accurate assessment of dynamic pulmonary volumes in cooperating patients who are unable to undergo conventional spirometry (e.g. patients with tracheostomy).

Первичные конечные точки

• Agreement between EIT-derived FEV1 and spirometry-derived FEV1 [Срок оценки: At baseline visit (single measurement)]

Вторичные конечные точки (9)

• Forced Expiratory Volume in One Second (FEV1) [Срок оценки: At baseline visit (single measurement)]
• Forced vital capacity (FVC) [Срок оценки: At baseline visit (single measurement)]
• Peak Expiratory Flow (PEF) [Срок оценки: At baseline visit (single measurement)]
• Estimated Lung Age (ELA) [Срок оценки: At baseline visit (single measurement)]
• Forced Expiratory Volume in Three Seconds (FEV3) [Срок оценки: At baseline visit (single measurement)]
• Forced Expiratory Volume in Six Seconds (FEV6) [Срок оценки: At baseline visit (single measurement]
• FEV1/FVC ratio [Срок оценки: At baseline visit (single measurement]
• Forced Expiratory Flow at 50 % of FVC (FEF50) [Срок оценки: At baseline visit (single measurement]
• Forced Expiratory Flow at 75 % of FVC (FEF75) [Срок оценки: At baseline visit (single measurement]

Критерии участия

Критерии включения

• Adults aged 18 years and older
• Individuals diagnosed with any of the following lung diseases, as these are the primary focus of the study: Chronic obstructive pulmonary disease, Asthma, Pulmonary fibrosis, Pneumonia, Patients with a history of COVID-19 infection showing residual pulmonary findings.
• Additionally, healthy subjects will be enrolled to obtain normal standard values (with normal physical examination and no respiratory symptoms, BMI 18-36 - cause EIT performance can be BMI dependent, Non-smokers or ex-smokers abstinent ≥12 months)
• Ability to perform spirometry while seated, except for possible participants who are specifically part of a subgroup analysis where inability to perform spirometry is the condition which is studied.

Signing of an informed consent that has been approved by the ethics committee

Критерии исключения

• Patients under 18 years of age
• Severe cardiovascular disease
• Pregnancy
• Inability to express consent
• Acute respiratory infection: Except for those recovering from pneumonia or COVID-19 within the study focus, participants with current respiratory infections will be excluded to avoid confounding effects on lung function tests
• Inability to perform spirometry

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Чехия · 1 центр

• Department of Pulmonary Diseases and Tuberculosis, University hospital Olomouc — Olomouc

Идентификаторы

NCT: NCT07356076 · OP JAK ITI VZ 3 · CZ.02.01.01/00/23_021/0008829

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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