PneumoniaNCT01818089
Monitoring of Lung Sounds of Patients With Pneumonia
An observational study of Pneumonia, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Lung sound analyzer
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with ambulant aquired pneumonia
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pneumonia
- Being tested
- Lung sound analyzer
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung sound analyzerDevice
Also called Electronic stethoscope, Model 3200, Littmann 3M
Patients will be aucultated with lung sound analyzer. The auscultation will be done three times daily during the duration of the complete hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Lung Sound Analyzer | Patient with pneumonia admitted to hospital will receive additional auscultation with lung sound analyzing stethoscope Receives: Device: Lung sound analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound of lungs
3 times a day for longest 5 days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Cornelissen, MD, Principal investigator, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818089
- Sponsor's protocol ID
- 12-116
- Status last verified
- Sep 2015
- First submitted
- 15 Feb 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Lung Sounds of Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT01818089
- Acronym / sponsor ID
- 12-116
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Sound Analyzer | – | Device: Lung sound analyzerPatient with pneumonia admitted to hospital will receive additional auscultation with lung sound analyzing stethoscope |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ambulant aquired pneumonia
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung sound analyzerAlso: Electronic stethoscope, Model 3200, Littmann 3MPatients will be aucultated with lung sound analyzer. The auscultation will be done three times daily during the duration of the complete hospital stay. | Device | Lung Sound Analyzer |
Primary outcome
Sound of lungs
Time frame: 5 days
3 times a day for longest 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Cornelissen, MD principal investigator
RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sound of lungs (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.