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

NCT04099225 | Completed DMC FDA Device

• 1 other identifier: MBW-normal values
• Study Type: observational
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Subjects; Smokers; Non-smokers

Outcome Measures

Primary Outcomes (1)

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

  global ventilation heterogeneity

  30 minutes

Secondary Outcomes (2)

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

  30 minutes

• Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)

  30 minutes

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers including never, active and former smokers

You may qualify if:

• 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

You may not qualify if:

• unwilling or unable to give informed consent
• history of any respiratory disease

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Related Publications (1)

• Trinkmann F, Maros M, Roth K, Hermanns A, Schafer J, Gawlitza J, Saur J, Akin I, Borggrefe M, Herth FJF, Ganslandt T. Multiple breath washout (MBW) testing using sulfur hexafluoride: reference values and influence of anthropometric parameters. Thorax. 2021 Apr;76(4):380-386. doi: 10.1136/thoraxjnl-2020-214717. Epub 2021 Feb 16.

  PMID: 33593931 DERIVED

Study Officials

• Frederik Trinkmann, MD

  University Medical Center Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 23, 2019
• Study Start: August 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share