Utility of Breath-holding Test for Assessment of Pulmonary Disease Severity in Patients With Systemic Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Systemic Sclerosis
- Sponsor
- Seoul National University Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Correlation of breath-holding test with Borg Dyspnea Index
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.
Detailed Description
Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc. Pulmonary involvement, such as pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) is a major cause of death in SSc. Although the 6MWT is generally used for evaluating PAH and ILD, the utility in SSc is undetermined. Several investigators have found weak or moderate correlations of 6MWT in pulmonary involvement in SSc. The 6MWT is influenced by the status of all organ systems involved in exercise (pulmonary, cardiac, peripheral vascular, neuromuscular unit and muscle metabolism) as well as by specifics of test conditions. There is a pressing need for new, practical method which corroborates the current 6MWT for the evaluation of pulmonary disease severity in SSc. Breath-holding test (BHT) is one of the most useful methods for assessing the sensitivity of peripheral chemoreflex. Recent studies have demonstrated that BHT was correlated to pulmonary function test. BHT can be safely conducted and doctors handle a medical emergency during test easily as well. Therefore, this study evaluates the utility of BHT as surrogate marker of pulmonary involvement in patients with SSc.
Investigators
Eun Bong Lee
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •A diagnosis of systemic sclerosis according to 2013 ACR/EULAR criteria
- •Must understand and voluntarily sign an informed consent form including writing consent for data protection
Exclusion Criteria
- •The resting oxygen saturation by pulse oximetry \< 90% in room air
- •Unstable angina or myocardial infarction during the previous month
- •Patients considered unable to the breath-holding test or 6 minute walk test
Outcomes
Primary Outcomes
Correlation of breath-holding test with Borg Dyspnea Index
Time Frame: Day 1 at inclusion
Borg Scale on a 0-10 point
Secondary Outcomes
- Correlation of breath-holding time with pulmonary function indices(Day 1 at inclusion)
- Correlation of breath-holding time with data on the echocardiography(Day 1 at inclusion)
- Correlation of breath-holding time with scleroderma health assessment questionnaire (SHAQ)(Day 1 at inclusion)
- Correlation of breath-holding time with 6 minute walk test (6MWT) distance(Day 1 at inclusion)
- Correlation of breath-holding time with oxygen saturation during 6MWT(Day 1 at inclusion)