NCT00767195

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

Enrollment Period

1.4 years

First QC Date

October 2, 2008

Last Update Submit

June 6, 2010

Conditions

Keywords

pulmonary edemacardiogenicnon-cardiogenicmortalitylength of stay

Study Arms (3)

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

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients without pulmonary edema (control group), with cardiogrnic edema (study group 1) and non-cardiogrnic edema (study group 2)

You may qualify if:

  • Patients in the intensive care unit using ventilator

You may not qualify if:

  • Asthma, COPD, non-ventilated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Low-Tone Ho, MD

    Taipei Veterans General Hospital, Taiwan

    STUDY CHAIR

Central Study Contacts

Cheng-Deng Kuo, MD,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 6, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 8, 2010

Record last verified: 2010-06

Locations