Department of Pulmonary Diseases and Tuberculosis, University hospital Olomouc
Olomouc, 77900, Czechia
Location status: Recruiting
Location contact
Jan Mizera, MD
CONTACT
Samuel Genzor, Assoc. prof., MD, Ph.D.
CONTACT
NCT Number: NCT07356076
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Olomouc, 77900, Czechia
Location status: Recruiting
Jan Mizera, MD
CONTACT
Samuel Genzor, Assoc. prof., MD, Ph.D.
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Signing of an informed consent that has been approved by the ethics committee
Exclusion criteria
Time frame: At baseline visit (single measurement)
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)
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)
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)
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)
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)
FEV3 represents the volume of air that can be exhaled during the first three seconds of forceful exhalation after maximum inspiration.
Unit of Measure: Liters
Time frame: At baseline visit (single measurement
FEV6 represents the volume of air that can be exhaled during the first six seconds of forceful exhalation after maximum inspiration
Unit of Measure: Liters
Time frame: At baseline visit (single measurement
FEV1/FVC is the ratio of forced expiratory volume in one second to forced vital capacity.
Unit of Measure: Percentage
Time frame: At baseline visit (single measurement
FEF50 is the flow rate at the 50% point of the total volume (FVC) exhaled.
Unit of Measure: Liters
Time frame: At baseline visit (single measurement
FEF75 is the flow rate at the 75% point of the total volume exhaled.
Unit of Measure: Liters
University Hospital Olomouc
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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