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

Completed

• Conditions: Healthy Subjects; Smokers; Non-smokers

• Registration Number: NCT04099225
• Lead Sponsor: Universitätsmedizin Mannheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2019-09
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-19
• Last Update Submitted: 2019-09-19
• Study First Posted: 2019-09-23
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lung clearance index (LCI) derived from multiple breath washout testing (MBW)	30 minutes	global ventilation heterogeneity

Secondary Outcome Measures

Name	Time	Method
Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)	30 minutes	local ventilation heterogeneity
Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW)	30 minutes	local ventilation heterogeneity