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

ConditionLung Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Olomouc

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Patients under 18 years of age

Severe cardiovascular disease

Pregnancy

Inability to express consent

Trial population

Patients of the Department of Pulmonary Diseases and Tuberculosis, University hospital Olomouc, and healthy controls.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Patients with lung diseases
Group B: Healthy controls

Trial outcomes

Primary outcomes

1

Agreement between EIT-derived FEV1 and spirometry-derived FEV1

Comparison of forced expiratory volume in 1 second predicted from EIT using a trained neural network with direct spirometry measurement. Metric: Mean Absolute Error (MAE), Bland-Altman limits of agreement, Pearson correlation coefficient (r)

Time frame
At baseline visit (single measurement)

Secondary outcomes

1

Forced Expiratory Volume in One Second (FEV1)

FEV1 represents the volume of air that can be forcibly exhaled in the first second of a forced exhalation Measurements will be performed using calibrated spirometry. FEV1 is a standard measure of pulmonary function. Unit of Measure: Liters

Time frame
At baseline visit (single measurement)
2

Forced vital capacity (FVC)

FVC represents the largest amount of air that can be forcefully exhaled from maximum inspiration. Unit of Measure: Liters

Time frame
At baseline visit (single measurement)
3

Peak Expiratory Flow (PEF)

PEF represents the maximum flow achieved during forceful exhalation from maximum inspiration and is a reliable indicator of ventilation adequacy as well as airflow obstruction. Unit of Measure: Liters/minute

Time frame
At baseline visit (single measurement)
4

Estimated Lung Age (ELA)

ELA is a calculation that estimates the age of a person's lungs based on their lung function, particurarly FEV1 (forced expiratory volume in one second), compared to normal lung function for their chronological age. Secondary objectives include comparison of regional ventilation patterns from EIT with spirometric flow-volume loop abnormalities, assessment of EIT-based estimated lung age, and determination of EIT's ability to track treatment response over time.

Time frame
At baseline visit (single measurement)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Olomouc

Lead sponsor

Brno University of Technology

Collaborator