Pulmonary EdemaNCT00767195
Power Spectral Analysis of Breath Sound in Pulmonary Edema
An observational study of Pulmonary Edema, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Pulmonary edema can be classified into "cardiogenic pulmonary edema" and "non-cardiogenic pulmonary edema" according to the underlying etiology. Cardiogenic pulmonary edema is caused by the dysfunction in the cardiac pumping capability, leading to the transudation accumulation in the pulmonary peri-capillary space. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Pulmonary Edema
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Dec 2009
- 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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients without pulmonary edema (control group), with cardiogrnic edema (study group 1) and non-cardiogrnic edema (study group 2)
Who may be able to join
- Patients in the intensive care unit using ventilator
Who cannot join
- Asthma, COPD, non-ventilated patients
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Intensive Care Unit
Taipei, 112
Cheng-Deng Kuo, MD, PhD, 886-2-28757745, cdkuo@vghtpe.gov.tw
Wen-Je Ko, MD
About this study
Official title: Power Spectral Analysis of Lung Sounds Detected at Bilateral Lung Bases in Patients With Cardiogenic and Non-cardiogenic Pulmonary Edema
Pulmonary edema can be classified into "cardiogenic pulmonary edema" and "non-cardiogenic pulmonary edema" according to the underlying etiology. Cardiogenic pulmonary edema is caused by the dysfunction in the cardiac pumping capability, leading to the transudation accumulation in the pulmonary peri-capillary space. The predisposing factors of non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure, auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high, especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early stage is important for its treatment.
Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases clinically. Among many kinds of lung sounds, the "crackle" and "rale" are frequently found in pulmonary edema. "Rale" is also called "moist rale". It is considered as low-frequency wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, "crackle" is also called "dry rale", which is a kind of high-frequency wheezes and usually seen in Acute Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.
This proposed project intends to establish a digital diagnostic method for pulmonary edema. The lung sound of patient with pulmonary edema will be collected by the lung sound acquisition system. By identifying the significant spectrum characteristics of cardiogenic pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be established.
Read the detailed description
Pulmonary edema is caused by the disorder of liquid accumulation between lung capillary and peri-capillary tissue. This lung disease can be classified into "Cardiogenic pulmonary edema" and "Non-cardiogenic pulmonary edema" according to the underlying etiology. Cardiogenic pulmonary edema is caused by the dysfunction in the cardiac pumping capability, leading to the transudation accumulation in the pulmonary peri-capillary space. Pulmonary ventilation and perfusion mismatch developed and shortness of breath ensued. The predisposing factors of non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure, auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high, especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early stage is important for its treatment.
Stethoscopes are widely used in clinical diagnosis in different diseases. Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases clinically. Among many kinds of lung sounds, the "crackle" and "rale" are frequently found in pulmonary edema. "Rale" is also called "moist rale". It is considered as low-frequency wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, "crackle" is also called "dry rale", which is a kind of high-frequency wheezes and usually seen in Acute Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.
By simply listening to the lung sounds, a doctor can determine whether the patient has pulmonary edema or not, and whether the pulmonary edema if present is cardiogenic or not. This listening diagnostic method is simple and non-invasive. However, its accuracy is limited by such factors as the doctor's subjectiveness and interference from other physiological signals. Also, it is sometimes difficult to distinguish cardiogenic pulmonary edema from non-cardiogenic pulmonary edema just by auscultation only. Advanced diagnostic method (such as echocardiography) is often needed for further evaluation of lung problems.
This proposed project intends to establish a digital diagnostic method for pulmonary edema by integrating the medical expertise and resources of NTUH (National Taiwan University Hospital) and the engineering ability of NCU-EE (Department of Electrical Engineering, National Central University) in computer, electronics, and signal processing. We will apply the developed tool to lung sound acquisition hardware system for pulmonary edema diagnosis and set up an electronic diagnostic system. The lung sound of patient with pulmonary edema will be collected by this lung sound acquisition hardware system for the establishment of a Pulmonary Edema Library. By identifying the significant spectrum characteristics of cardiogenic pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be established.
- Conditions
- Pulmonary Edema
- Keywords
- pulmonary edema, cardiogenic, non-cardiogenic, mortality, length of stay
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Control group | Patients in the intensive care unit who have no pulmonary edema | |
| 2. Study group 1 | Patients with cardiogenic pulmonary edema in the intensive care unit | |
| 3. Study group 2 | Patients with non-cardiogenic pulmonary edema in the intensive care unit |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Taiwan University Hospital
- Investigators
- Low-Tone Ho, MD, Study chair, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767195
- Sponsor's protocol ID
- VGHIRB97-01-02A
- Other IDs
- 200808065R
- Status last verified
- Jun 2010
- First submitted
- 2 Oct 2008
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Spectral Analysis of Lung Sounds Detected at Bilateral Lung Bases in Patients With Cardiogenic and Non-cardiogenic Pulmonary Edema
- ClinicalTrials.gov ID
- NCT00767195
- Acronym / sponsor ID
- VGHIRB97-01-02A
- Conditions
- Pulmonary Edema
- Keywords
- pulmonary edema, cardiogenic, non-cardiogenic, mortality, length of stay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Taiwan University Hospital
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 Oct 2008 (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.
Pulmonary edema can be classified into "cardiogenic pulmonary edema" and "non-cardiogenic pulmonary edema" according to the underlying etiology. Cardiogenic pulmonary edema is caused by the dysfunction in the cardiac pumping capability, leading to the transudation accumulation in the pulmonary peri-capillary space. The predisposing factors of non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure, auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high, especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early stage is important for its treatment.
Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases clinically. Among many kinds of lung sounds, the "crackle" and "rale" are frequently found in pulmonary edema. "Rale" is also called "moist rale". It is considered as low-frequency wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, "crackle" is also called "dry rale", which is a kind of high-frequency wheezes and usually seen in Acute Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.
This proposed project intends to establish a digital diagnostic method for pulmonary edema. The lung sound of patient with pulmonary edema will be collected by the lung sound acquisition system. By identifying the significant spectrum characteristics of cardiogenic pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be established.
Detailed description
Pulmonary edema is caused by the disorder of liquid accumulation between lung capillary and peri-capillary tissue. This lung disease can be classified into "Cardiogenic pulmonary edema" and "Non-cardiogenic pulmonary edema" according to the underlying etiology. Cardiogenic pulmonary edema is caused by the dysfunction in the cardiac pumping capability, leading to the transudation accumulation in the pulmonary peri-capillary space. Pulmonary ventilation and perfusion mismatch developed and shortness of breath ensued. The predisposing factors of non-cardiogenic pulmonary edema are numerous, including severe infection, renal failure, auto-immun reaction, etc. The mortality rate of pulmonary edema is relatively high, especially the non-cardiogenic one. To distinguish the type of pulmonary edema at the early stage is important for its treatment.
Stethoscopes are widely used in clinical diagnosis in different diseases. Lung sound analysis via stethoscope is a simple diagnostic method to lung diseases clinically. Among many kinds of lung sounds, the "crackle" and "rale" are frequently found in pulmonary edema. "Rale" is also called "moist rale". It is considered as low-frequency wheezes and is often seen in cardiogenic pulmonary edema. On the other hand, "crackle" is also called "dry rale", which is a kind of high-frequency wheezes and usually seen in Acute Respiratory Distress Syndrome (ARDS) that is classified into non-cardiogenic pulmonary edema.
By simply listening to the lung sounds, a doctor can determine whether the patient has pulmonary edema or not, and whether the pulmonary edema if present is cardiogenic or not. This listening diagnostic method is simple and non-invasive. However, its accuracy is limited by such factors as the doctor's subjectiveness and interference from other physiological signals. Also, it is sometimes difficult to distinguish cardiogenic pulmonary edema from non-cardiogenic pulmonary edema just by auscultation only. Advanced diagnostic method (such as echocardiography) is often needed for further evaluation of lung problems.
This proposed project intends to establish a digital diagnostic method for pulmonary edema by integrating the medical expertise and resources of NTUH (National Taiwan University Hospital) and the engineering ability of NCU-EE (Department of Electrical Engineering, National Central University) in computer, electronics, and signal processing. We will apply the developed tool to lung sound acquisition hardware system for pulmonary edema diagnosis and set up an electronic diagnostic system. The lung sound of patient with pulmonary edema will be collected by this lung sound acquisition hardware system for the establishment of a Pulmonary Edema Library. By identifying the significant spectrum characteristics of cardiogenic pulmonary edema and non-cardiogenic pulmonary edema, the diagnostic system might be established.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Control group | – | –Patients in the intensive care unit who have no pulmonary edema |
| 2. Study group 1 | – | –Patients with cardiogenic pulmonary edema in the intensive care unit |
| 3. Study group 2 | – | –Patients with non-cardiogenic pulmonary edema in the intensive care unit |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without pulmonary edema (control group), with cardiogrnic edema (study group 1) and non-cardiogrnic edema (study group 2)
Key inclusion criteria (1 listed)
- Patients in the intensive care unit using ventilator
Key exclusion criteria (1 listed)
- Asthma, COPD, non-ventilated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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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.
Low-Tone Ho, MD study chair
Taipei Veterans General Hospital, Taiwan
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 Pulmonary Edema, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2010. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Deng Kuo, MD,PhD (886-2-28757745, cdkuo@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 8 Jun 2010.