Monitoring of Lung Sounds of Patients With Pneumonia | NCT01818089

Studies
Monitoring of Lung Sounds of Patients With Pneumonia

NCT01818089

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

17Actual

Phase

Not provided

Conditions

Pneumonia

Interventions

Lung sound analyzer

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

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Feb 15, 2013

First Submission Date that Met QC Criteria

Mar 21, 2013

First Posted Date

Mar 26, 2013Estimated

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

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 aim of this study is to investigate if any correlation between lung sounds of pneumonia patients and the clinical development or therapy of the pneumonia exists.

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

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung Sound Analyzer		Patient with pneumonia admitted to hospital will receive additional auscultation with lung sound analyzing stethoscope	Device: Lung sound analyzer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lung sound analyzer	Device	Patients will be aucultated with lung sound analyzer. The auscultation will be done three times daily during the duration of the complete hospital stay.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sound of lungs	3 times a day for longest 5 days	5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ambulant aquired pneumonia with typically radiological signs
hospitalisation at medical clinic I, university hospital Aachen
age at least > 18 years
CRB-65 score > 1
CRP> 60mg/l
fever
lung sounds audible by stethoscope
legal capacity and being able to understand and to follow the instructions of the study staff
being able to consent and being able to understand the importance and the consequence of the study
not being accomondated in an institution

Exclusion Criteria:

pneumonia acquired in a hospital
artificial respiration or other means for supporting respiration
allergic reaction because of skin contact with polymers
pregnancy or breast feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients with ambulant aquired pneumonia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Cornelissen, MD	RWTH Aachen University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy Hospital Aachen		Aachen	North Rhine Westfalia	52074	Germany

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided