Application and Generalization of Flutter Mucus Clearance Device

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: flutter mucus clearance device

• Registration Number: NCT00816881
• Lead Sponsor: Tongji University

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-02
• Study First Submitted QC: 2009-01-02
• Study First Posted: 2009-01-05
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	flutter mucus clearance device	flutter mucus clearance device

Primary Outcome Measures

Name	Time	Method
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days	one year

Secondary Outcome Measures

Name	Time	Method
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital	one year

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China