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Evaluation of Postural Effects on Multiple-breath-washout Derived Lung Function Parameters

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ClinicalTrials.gov Identifier: NCT02826239
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Frederik Trinkmann, Universitätsmedizin Mannheim

Brief Summary:
The investigators aim to evaluated the effect of postural changes on novel lung function parameters derived from multiple-breath-washout.

Condition or disease Intervention/treatment
Pulmonary Healthy Controls Pulmonary Disease Device: multiple breath washout test (MBW)

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluation of Postural Effects on Multiple-breath-washout Derived Lung Function Parameters
Study Start Date : February 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Group/Cohort Intervention/treatment
pulmonary healthy controls
patients without known pulmonary disease
Device: multiple breath washout test (MBW)
measured in upright and supine position

pulmonary disease
patients with known or suspected pulmonary disease
Device: multiple breath washout test (MBW)
measured in upright and supine position




Primary Outcome Measures :
  1. change of lung clearance index (LCI) as determined by multiple breath washout [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. repeatability of lung clearance index (LCI) [ Time Frame: 60 minutes ]


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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
patients with and without known pulmonary disease
Criteria

Inclusion Criteria:

  • patients with and without known pulmonary disease

Exclusion Criteria:

  • pregnancy
  • inability to participate

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): NCT02826239


Contacts
Contact: Frederik Trinkmann, Dr. +496213833879 frederik.trinkmann@umm.de

Locations
Germany
Universitätsmedizin Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Frederik Trinkmann, Dr.    +496213833879    frederik.trinkmann@umm.de   
Principal Investigator: Frederik Trinkmann, Dr.         
Principal Investigator: Joachim Saur, Prof. Dr.         
Sponsors and Collaborators
Universitätsmedizin Mannheim

Responsible Party: Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02826239     History of Changes
Other Study ID Numbers: MBW-posture
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases