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

September 19, 2019 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers including never, active and former smokers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung clearance index (LCI) derived from multiple breath washout testing (MBW)
Time Frame: 30 minutes
global ventilation heterogeneity
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acinar phase-III-slope (Sacin) derived from multiple breath washout testing (MBW)
Time Frame: 30 minutes
local ventilation heterogeneity
30 minutes
Conductive phase-III-slope (Scond) derived from multiple breath washout testing (MBW)
Time Frame: 30 minutes
local ventilation heterogeneity
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Frederik Trinkmann, MD, University Medical Center Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • MBW-normal values

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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).

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Subjects

Clinical Trials on Multiple breath washout (MBW) testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe