Evaluation of Postural Effects on Multiple-breath-washout... | NCT02826239

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

NCT02826239

Sponsor

Universitätsmedizin Mannheim

Status

Unknown status

Last Update Posted

Mar 24, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Pulmonary Healthy Controls
Pulmonary Disease

Interventions

multiple breath washout test (MBW)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 30, 2016

First Submission Date that Met QC Criteria

Jul 5, 2016

First Posted Date

Jul 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pulmonary healthy controls		patients without known pulmonary disease	Device: multiple breath washout test (MBW)
pulmonary disease		patients with known or suspected pulmonary disease	Device: multiple breath washout test (MBW)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
multiple breath washout test (MBW)	Device	measured in upright and supine position	pulmonary disease pulmonary healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of lung clearance index (LCI) as determined by multiple breath washout		60 minutes

Secondary Outcomes

Measure	Description	Time Frame
repeatability of lung clearance index (LCI)		60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with and without known pulmonary disease

Exclusion Criteria:

pregnancy
inability to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with and without known pulmonary disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frederik Trinkmann, Dr.	Contact	+496213833879		frederik.trinkmann@umm.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsmedizin Mannheim	Recruiting	Mannheim		68167	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided