Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

Pulmonary Disease Clinical Trial

Official title:

Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881335
• Other study ID #: SHDC12007211-O
• Status: Completed
• Phase: N/A
• First received: April 14, 2009
• Last updated: June 25, 2012
• Start date: April 2009
• Est. completion date: May 2009

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 in elders of gerocomium.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 85 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)		up to 28 days	Yes
Primary	MPEF,Mean Peak Expiratory Flow	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.	up to 28 days	Yes
Primary	FEV1, Forced Expiratory Volume at First Second	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.	up to 28 days	Yes
Primary	FVC, Forced Vital Capacity	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.	up to 28 days	Yes
Primary	FEV1/FVC%, the Ratio of FEV1 to FVC	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.	up to 28 days	Yes
Secondary	Number of Cases With Antibiotics Therapy	antibiotics therapy is the indicators of pulmonary infection	up to 28 days	Yes
Secondary	Number of Cases With Hospital Visit		up to 28 days	Yes