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Application and Generalization of Flutter Mucus Clearance Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816881
First Posted: January 5, 2009
Last Update Posted: June 22, 2012
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.
Information provided by (Responsible Party):
Zhang Xiangyu, Tongji University
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Application and Generalization of Flutter Mucus Clearance Device

Further study details as provided by Zhang Xiangyu, 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 ]

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 ]

Enrollment: 356
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
flutter mucus clearance device
Device: flutter mucus clearance device
five minutes every session, four sessions per day
No Intervention: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00816881


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhang Xiangyu, Director, Tongji University
ClinicalTrials.gov Identifier: NCT00816881     History of Changes
Other Study ID Numbers: SHDC12007211
First Submitted: January 2, 2009
First Posted: January 5, 2009
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Zhang Xiangyu, Tongji University:
Pulmonary Disease, Chronic Obstructive
flutter
airway clearance
sputum
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