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Application and Generalization of Flutter Mucus Clearance Device

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhang Xiangyu, Tongji University
ClinicalTrials.gov Identifier:
NCT00816881
First received: January 2, 2009
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Application and Generalization of Flutter Mucus Clearance Device

Resource links provided by NLM:

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 ]

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

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
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

No publications provided

Responsible Party: Zhang Xiangyu, Director, Tongji University
ClinicalTrials.gov Identifier: NCT00816881     History of Changes
Other Study ID Numbers: SHDC12007211
Study First Received: January 2, 2009
Last Updated: June 21, 2012
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 23, 2013