Healthy SubjectsNCT04099225
Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters
An observational study of Healthy Subjects and Smokers, run by Universitätsmedizin Mannheim.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Smokers, Non-smokers
- What is being tested?
- Multiple breath washout (MBW) testing
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers including never, active and former smokers
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- unwilling or unable to give informed consent
- history of any respiratory disease
About this study
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
- Being tested
- Multiple breath washout (MBW) testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple breath washout (MBW) testingDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung clearance index (LCI) derived from multiple breath washout testing (MBW)
global ventilation heterogeneity
Measured: 30 minutes
Secondary outcomes (2)
Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW)
local ventilation heterogeneity
Measured: 30 minutes
Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)
local ventilation heterogeneity
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study startAug 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
- Investigators
- Frederik Trinkmann, MD, Principal investigator, University Medical Center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099225
- Sponsor's protocol ID
- MBW-normal values
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Sharing of individual participant data is prohibited by data protection regulations. Summarized data including the models will be made available thru an online repository (GitHub).
Publications
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.
PubMed 33593931
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters
- ClinicalTrials.gov ID
- NCT04099225
- Acronym / sponsor ID
- MBW-normal values
- Conditions
- Healthy Subjects, Smokers, Non-smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers including never, active and former smokers
Key inclusion criteria (13 listed)
- non-smoker
- no history of pulmonary disease
- absence of dyspnoea, cough, thoracic pain
- no self-reported smoking history
- normal lung function testing
Key exclusion criteria (2 listed)
- unwilling or unable to give informed consent
- history of any respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple breath washout (MBW) testingLung 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. | Diagnostic test | – |
Primary outcome
Lung clearance index (LCI) derived from multiple breath washout testing (MBW)
Time frame: 30 minutes
global ventilation heterogeneity
2 secondary outcomes
Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW)
Time frame: 30 minutes
Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Derived from this study: PubMed 33593931Trinkmann 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.
- Individual participant dataSharing planned: No. Sharing of individual participant data is prohibited by data protection regulations. Summarized data including the models will be made available thru an online repository (GitHub).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Trinkmann, MD principal investigator
University Medical Center Mannheim
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects and Smokers, run by Universitätsmedizin Mannheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung clearance index (LCI) derived from multiple breath washout testing (MBW) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.