Application and Generalization of Flutter Mucus Clearance Device

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Application and Generalization of Flutter Mucus Clearance Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816881
• Other study ID #: SHDC12007211
• Status: Completed
• Phase: N/A
• First received: January 2, 2009
• Last updated: June 21, 2012
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2012
• Source: Tongji University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• flutter mucus clearance device
five minutes every session, four sessions per day

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital		one year	Yes