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
  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:


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 April 14, 2014