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This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic sclerosis group | Experimental | Systemic sclerosis diagnosis according to 2013 American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) classification criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of breath-holding test with Borg Dyspnea Index | Borg Scale on a 0-10 point | Day 1 at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of breath-holding time with 6 minute walk test (6MWT) distance | 6MWT distance measured in meters according to American Thoracic Society guidelines | Day 1 at inclusion |
| Correlation of breath-holding time with oxygen saturation during 6MWT |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of oxygen saturation during breath-holding test | Oxygen saturation monitored by radius or forehead pulse oximeter (Masimo Corp., Irvine, CA, USA) | Day 1 at inclusion |
| Changes of oxygen saturation during of 6MWT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eun Bong Lee, MD PhD | Seoul National University College of Medicine | Principal Investigator |
| Jina Yeo, MD | Seoul National University College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20143182 | Background | Hachulla E, Launay D. Diagnosis and classification of systemic sclerosis. Clin Rev Allergy Immunol. 2011 Apr;40(2):78-83. doi: 10.1007/s12016-010-8198-y. | |
| 11028845 | Background | Morelli S, Ferrante L, Sgreccia A, Eleuteri ML, Perrone C, De Marzio P, Balsano F. Pulmonary hypertension is associated with impaired exercise performance in patients with systemic sclerosis. Scand J Rheumatol. 2000;29(4):236-42. doi: 10.1080/030097400750041389. |
| Label | URL |
|---|---|
| Azza Slim, Abir Hedhli, Sana Cheikh Rouhou, et al. Maximal voluntary inspiratory breath holding time test in patients with chronic obstructive pulmonary disease. European Respiratory Journal 2018 52:PA4053 | View source |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002084 | Butylated Hydroxytoluene |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
Oxygen saturation monitored by wearable pulse oximeter (Radius PPG™ Tetherless Pulse Oximetry, Masimo Corp., Irvine, CA, USA)
| Day 1 at inclusion |
| Correlation of breath-holding time with pulmonary function indices | Pulmonary function indices including FVC (%) and DLCO (%) | Day 1 at inclusion |
| Correlation of breath-holding time with data on the echocardiography | Echocardiography including left ventricular ejection fraction and pulmonary arterial systolic pressure (mmHg) | Day 1 at inclusion |
| Correlation of breath-holding time with scleroderma health assessment questionnaire (SHAQ) | SHAQ ranging from 0 to 3 | Day 1 at inclusion |
Oxygen saturation monitored by wearable pulse oximeter (Radius PPG™ Tetherless Pulse Oximetry, Masimo Corp., Irvine, CA, USA)
| Day 1 at inclusion |
| Responsiveness of breath-holding test | Correlation of Δbreath-holding test and ΔPulmonary function indices after 6months | Month 6 at inclusion |
| Reliability of breath-holding test | Additional 30 patients collection for test-retest reliability | Day 1, and Day 7~Day14 at inclusion |
| Development of the machine learning model to predict pulmonary parameters | Developing two cohorts: Cohort 1 for training a ML model and internal validation; and Cohort 2 for external validation | Year 2 at inclusion |
| 27057932 | Background | Vandecasteele E, De Pauw M, De Keyser F, Decuman S, Deschepper E, Piette Y, Brusselle G, Smith V. Six-minute walk test in systemic sclerosis: A systematic review and meta-analysis. Int J Cardiol. 2016 Jun 1;212:265-73. doi: 10.1016/j.ijcard.2016.03.084. Epub 2016 Mar 25. |
| 18784152 | Background | Impens AJ, Wangkaew S, Seibold JR. The 6-minute walk test in scleroderma--how measuring everything measures nothing. Rheumatology (Oxford). 2008 Oct;47 Suppl 5:v68-9. doi: 10.1093/rheumatology/ken273. |
| 12091180 | Background | ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. |
| 35040945 | Derived | Yeo J, Kim JY, Kim MH, Park JW, Park JK, Lee EB. Utility of the breath-holding test in patients with systemic sclerosis. Rheumatology (Oxford). 2022 Oct 6;61(10):4113-4118. doi: 10.1093/rheumatology/keac020. |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |