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NCT04099225 Clinical Trial

Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters

Healthy Subjects Clinical Trial

Official title:
Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04099225
Other study ID # MBW-normal values
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2015
Est. completion date May 2019

Study information
Verified date September 2019
Source Universitätsmedizin Mannheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Multiple breath washout (MBW) using Sulphur hexafluoride (SF6) has the potential to reveal ventilation heterogeneity in obstructive lung disease which is frequent in patients with small airway disease. However, it is missed by commonly used tests with reference data being scarce and mostly restricted to younger collectives. We aimed to evaluate the influence of anthropometric parameters on SF6-MBW reference values in pulmonary healthy adults.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

non-smoker

- no history of pulmonary disease

- absence of dyspnoea, cough, thoracic pain

- no self-reported smoking history

- normal lung function testing

- normal shape of flow-volume curve

- normal shape of flow-pressure curve

- FEV1/FVC >70% (forced expiratory volume in 1 second / forced vital capacity)

- TLC > 80% of predicted (total lung capacity)

- TLCO/VA > 80% of predicted (transfer factor corrected for ventilated alveolar volume)

- R5 < 150% of predicted (resistance at 5Hz, impulse oscillometry)

smoker

- as above, but with self-reported smoking history >10 pack years

Exclusion Criteria:

- unwilling or unable to give informed consent

- history of any respiratory disease

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Multiple breath washout (MBW) testing
Lung clearance index (LCI), acinar (Sacin) and conductive (Scond) ventilation heterogeneity were derived from triplicate SF6-MBW measurements. Global ventilation heterogeneity was calculated for the 2.5% (LCI2.5) and 5% (LCI5) stopping points.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Outcome
Type Measure Description Time frame Safety issue
Primary Lung clearance index (LCI) derived from multiple breath washout testing (MBW) global ventilation heterogeneity 30 minutes
Secondary Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW) local ventilation heterogeneity 30 minutes
Secondary Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW) local ventilation heterogeneity 30 minutes
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