Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099225
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Frederik Trinkmann, 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.

Condition or disease Intervention/treatment
Healthy Subjects Smokers Non-smokers Diagnostic Test: Multiple breath washout (MBW) testing

Layout table for study information
Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters
Actual Study Start Date : August 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Lung clearance index (LCI) derived from multiple breath washout testing (MBW) [ Time Frame: 30 minutes ]
    global ventilation heterogeneity


Secondary Outcome Measures :
  1. Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW) [ Time Frame: 30 minutes ]
    local ventilation heterogeneity

  2. Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW) [ Time Frame: 30 minutes ]
    local ventilation heterogeneity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers including never, active and former smokers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099225


Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Layout table for investigator information
Principal Investigator: Frederik Trinkmann, MD University Medical Center Mannheim
Layout table for additonal information
Responsible Party: Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT04099225    
Other Study ID Numbers: MBW-normal values
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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).

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No