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

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.

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Key information

Conditions

Healthy Subjects Non-smokers Smokers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple breath washout (MBW) testing

Diagnostic Test

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.

Primary outcomes

Lung clearance index (LCI) derived from multiple breath washout testing (MBW)

Time frame: 30 minutes

global ventilation heterogeneity

Secondary outcomes

Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW)

Time frame: 30 minutes

local ventilation heterogeneity
Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)

Time frame: 30 minutes

local ventilation heterogeneity

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Sep 23, 2019
Registry last updated: Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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