Detection of Early Airway Obstruction in Patients with COPD Using RCexp

COPD Clinical Trial

— COPD TiCON  

Official title:

Detection of Early Airway Obstruction in Patients with Chronic Obstructive Pulmonary Disease Using Expiratory Time Constant

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456047
• Other study ID #: VUSCH
• Status: Not yet recruiting
• Start date: January 1, 2025
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: East Slovak Institute for Cardiovascular Diseases
• Contact: Filip Depta, MD PhD
• Phone: +421948507269
• Email: fdepta[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We hypothesize that Cexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.

Description:

Chronic obstructive pulmonary disease (COPD) is the most common chronic lung disease worldwide, leading to significant morbidity, mortality, and high treatment costs. In 2020, the global prevalence of COPD was estimated to be 10.6%, affecting around 480 million people. The diagnosis of COPD in suspected patients is typically confirmed through routine spirometry, a simple noninvasive test that assesses the degree of airway obstruction. However, research has revealed that extensive small airway disease exists in COPD before it can be detected using traditional spirometric measures, such as forced expiratory volume in the first second (FEV1) and the ratio of FEV1 to forced expiratory capacity (FEV1/FVC). Efforts are underway to find new parameters to improve early detection of airway obstruction in patients with COPD. The expiratory time constant (RCexp) is a promising variable studied in critical care medicine and may also prove useful in pulmonology. Data from ventilated COPD patients demonstrate that prolonged RCexp was present in all patients with COPD. The FEV1/FVC ratio is currently the gold standard for diagnosing COPD, but it only yields a single calculated value. In contrast, RCexp may offer more precision as it reflects exhalation dynamics at multiple time points during exhalation. If there is a prolongation of subsequent RCexp towards the end of exhalation, it could indicate the presence of obstruction. We hypothesize that RCexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: all patients eligible for routine spirometry if indicated as per the standard of care - Exclusion Criteria: known pulmonary disease, post thoracic surgery -

Related Conditions & MeSH terms

• Airway Obstruction
• COPD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
East Slovak Institute for Cardiovascular Diseases

References & Publications (1)

Depta F, Euliano NR, Zdravkovic M, Torok P, Gentile MA. Time constant to determine PEEP levels in mechanically ventilated COVID-19 ARDS: a feasibility study. BMC Anesthesiol. 2022 Dec 13;22(1):387. doi: 10.1186/s12871-022-01935-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of early airway obstruction and positivity of RCexp	research correlation of RCexp1, RCexp2, and RCexp3 with FEV1 and FEV1/FVC in patients with known COPD and its correlation with healthy controls	January 2025 - December 2028