Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
June 2, 2017 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
Determination of the Optimal Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
153
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 to 99 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
inpatients, outpatients, students, employees
Description
Inclusion criteria:
- informed consent
Exclusion Criteria:
- inability to perform multiple breath washout testing
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy controls
|
determination of lung clearance index using SF6 multiple breath washout
|
|
chronic obstructive pulmonary disease
|
determination of lung clearance index using SF6 multiple breath washout
|
|
bronchial asthma
|
determination of lung clearance index using SF6 multiple breath washout
|
|
sarcoidosis
|
determination of lung clearance index using SF6 multiple breath washout
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of lung clearance index (LCI) as determined by multiple breath washout
Time Frame: 60 minutes
|
comparing the repeatability of duplicate vs. triplicate LCI measurements
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
July 1, 2015
Primary Completion (ACTUAL)
June 30, 2016
Study Completion (ACTUAL)
January 15, 2017
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (ACTUAL)
June 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 5, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBW-number
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.