Viewing Study NCT06456047



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06456047
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-13
First Post: 2024-06-06

Brief Title: Detection of Early Airway Obstruction in Patients with COPD Using RCexp
Sponsor: East Slovak Institute for Cardiovascular Diseases
Organization: East Slovak Institute for Cardiovascular Diseases

Study Overview

Official Title: Detection of Early Airway Obstruction in Patients with Chronic Obstructive Pulmonary Disease Using Expiratory Time Constant
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COPD TiCON
Brief 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 FEV1FVC
Detailed 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 106 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 FEV1FVC 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 FEV1FVC 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 FEV1FVC

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None