Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

Not Applicable

Completed

• Conditions: Pulmonary Disease
• Interventions: Device: flutter mucus clearance device

• Registration Number: NCT00881335
• Lead Sponsor: Tongji University

Brief Summary

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

Detailed Description

Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2009-06-17
• Results First Submitted QC: 2012-05-17
• Status Verified: 2012-06
• Results First Posted: 2012-06-20
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• available to perform the device, the elders in geracomium
• male and female
• aging 85 years or more

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
• active hemoptysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	flutter mucus clearance device	Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise

Primary Outcome Measures

Name	Time	Method
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)	up to 28 days
MPEF,Mean Peak Expiratory Flow	up to 28 days	indicators of pulmonary function, for example, PEF(unit of measurement:Liter per minute) All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
FEV1, Forced Expiratory Volume at First Second	up to 28 days	indicators of pulmonary function, for example, FEV1(unit of measurement:Liter); All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
FVC, Forced Vital Capacity	up to 28 days	indicators of pulmonary function, for example, FVC(unit of measurement:Liter); All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.
FEV1/FVC%, the Ratio of FEV1 to FVC	up to 28 days	indicators of pulmonary function,; All subjects sit upright in a chair and instructed to perform the pulmonary function test. Repeat the test until three reproducible acceptable results are obtained. Spirometry was performed at the first day of baseline and the 28th day of our study.

Secondary Outcome Measures

Name	Time	Method
Number of Cases With Antibiotics Therapy	up to 28 days	antibiotics therapy is the indicators of pulmonary infection
Number of Cases With Hospital Visit	up to 28 days