Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

• ClinicalTrials.gov Identifier: NCT00881335
• Recruitment Status: Completed
• First Posted: April 15, 2009
• Results First Posted: June 20, 2012
• Last Update Posted: June 29, 2012
• Sponsor: Tongji University
• Information provided by (Responsible Party): Zhang Xiangyu, Tongji University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease	Device: flutter mucus clearance device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
• Study Start Date: April 2009
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
No Intervention: control group
Experimental: intervention; Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise	Device: flutter mucus clearance device; five minutes every sessions, three sessions per day

Outcome Measures

Primary Outcome Measures :

1. Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) [ Time Frame: up to 28 days ]
2. MPEF,Mean Peak Expiratory Flow [ Time Frame: 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.
3. FEV1, Forced Expiratory Volume at First Second [ Time Frame: 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.

4. FVC, Forced Vital Capacity [ Time Frame: 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.

5. FEV1/FVC%, the Ratio of FEV1 to FVC [ Time Frame: 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 :

1. Number of Cases With Antibiotics Therapy [ Time Frame: up to 28 days ]
   antibiotics therapy is the indicators of pulmonary infection
2. Number of Cases With Hospital Visit [ Time Frame: up to 28 days ]

Eligibility Criteria

• Ages Eligible for Study: 85 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Tongji University

Investigators

• Principal Investigator: Zhang Xiangyu, MD; Shanghai Tebth People's Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on pulmonary function test results in healthy people 85 years and older in China. Respir Care. 2010 Nov;55(11):1449-52.

• Responsible Party: Zhang Xiangyu, MD, director, professor, FCCM, FCCP., Tongji University
• ClinicalTrials.gov Identifier: NCT00881335
• Other Study ID Numbers: SHDC12007211-O
• First Posted: April 15, 2009
• Results First Posted: June 20, 2012
• Last Update Posted: June 29, 2012
• Last Verified: June 2012

Keywords provided by Zhang Xiangyu, Tongji University:

geriatric; pulmonary disease; flutter; sputum; physical therapy techniques

Additional relevant MeSH terms:

Lung Diseases; Respiratory Tract Diseases