Application and Generalization of Flutter Mucus Clearance Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00816881
Recruitment Status : Completed
First Posted : January 5, 2009
Last Update Posted : June 22, 2012
Information provided by (Responsible Party):
Zhang Xiangyu, Tongji University

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

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Device: flutter mucus clearance device

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Application and Generalization of Flutter Mucus Clearance Device
Study Start Date : January 2009
Primary Completion Date : February 2010
Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: 1
flutter mucus clearance device
Device: flutter mucus clearance device
five minutes every session, four sessions per day
No Intervention: 2

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00816881

China, Shanghai
Shanghai Tenth People's Hospital
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Tongji University
Principal Investigator: Zhang Xiangyu, MD Shanghai 10th People's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Zhang Xiangyu, Director, Tongji University Identifier: NCT00816881     History of Changes
Other Study ID Numbers: SHDC12007211
First Posted: January 5, 2009    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Zhang Xiangyu, Tongji University:
Pulmonary Disease, Chronic Obstructive
airway clearance
Physical Therapy Techniques

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive