Application and Generalization of Flutter Mucus Clearance Device - Full Text View

Sponsored by:	Tongji University
Information provided by:	Tongji University
ClinicalTrials.gov Identifier:	NCT00816881

Purpose

The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.

Condition	Intervention
Pulmonary Disease, Chronic Obstructive	Device: flutter mucus clearance device

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Application and Generalization of Flutter Mucus Clearance Device

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Tongji University:

Primary Outcome Measures:

days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	960
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental flutter mucus clearance device	Device: flutter mucus clearance device five minutes every session, four sessions per day
2: No Intervention Observation

Detailed Description:

Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pulmonary department: available to perform the device, in-hospital patients
- Male and female
- Age: 45 - 85 years
- Chronic bronchitis, COPD
Thoracic surgery department and surgical department (upper abdomen):
- Patients with endotracheal intubation of general anesthesia
- Age: 40-75 years

Exclusion Criteria:

Not available to perform the procedure
Untreated pneumothorax
Diffusion interstitial lung disease
Acute coronary syndrome
Third stage hypertension
Advanced cancer
Severe heart, liver, renal , blood system and endocrine system dysfunction
Noninvasive mechanical ventilation more than 6 hrs per day
Patients with invasive ventilation and cannot weaning and extubation within 48 hours
Active hemoptysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816881

Locations

China
Shanghai Tenth People's Hospital
Shanghai, China, 200072

Sponsors and Collaborators

Tongji University

Investigators

Principal Investigator:

Zhang Xiangyu, MD

Shanghai Tenth People'S Hospital

More Information

No publications provided

Responsible Party:	SICU, Shanghai Tenth People's Hospital, Shanghai Tongji University ( Zhang, Xiangyu, / MD, FCCP. )
Study ID Numbers:	SHDC12007211
Study First Received:	January 2, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00816881 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Tongji University:

Pulmonary Disease, Chronic Obstructive
flutter
airway clearance
sputum
Physical Therapy Techniques

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 02, 2009