Power Spectral Analysis of Breath Sound in Pulmonary Edema
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 2, 2008 | ||||
| Last Updated Date | June 6, 2010 | ||||
| Start Date ICMJE | July 2008 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00767195 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Power Spectral Analysis of Breath Sound in Pulmonary Edema | ||||
| Official Title ICMJE | Power Spectral Analysis of Lung Sounds Detected at Bilateral Lung Bases in Patients With Cardiogenic and Non-cardiogenic Pulmonary Edema | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients without pulmonary edema (control group), with cardiogrnic edema (study group 1) and non-cardiogrnic edema (study group 2) |
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| Condition ICMJE | Pulmonary Edema | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00767195 | ||||
| Other Study ID Numbers ICMJE | VGHIRB97-01-02A, 200808065R | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Cheng-Deng Kuo, MD, PhD, Professor, Taipei Veterans General Hospital | ||||
| Study Sponsor ICMJE | Taipei Veterans General Hospital,Taiwan | ||||
| Collaborators ICMJE | National Taiwan University Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Taipei Veterans General Hospital,Taiwan | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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