Back to resultsImplemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Primary Purpose
Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
flutter mucus clearance device
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Disease focused on measuring geriatric, pulmonary disease, flutter, sputum, physical therapy techniques
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
intervention
Arm Description
Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise
Outcomes
Primary Outcome Measures
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
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.
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.
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.
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.
Secondary Outcome Measures
Number of Cases With Antibiotics Therapy
antibiotics therapy is the indicators of pulmonary infection
Number of Cases With Hospital Visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00881335
Brief Title
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Official Title
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease
Keywords
geriatric, pulmonary disease, flutter, sputum, physical therapy techniques
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Title
intervention
Arm Type
Experimental
Arm Description
Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise
Intervention Type
Device
Intervention Name(s)
flutter mucus clearance device
Intervention Description
five minutes every sessions, three sessions per day
Primary Outcome Measure Information:
Title
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
Time Frame
up to 28 days
Title
MPEF,Mean Peak Expiratory Flow
Description
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.
Time Frame
up to 28 days
Title
FEV1, Forced Expiratory Volume at First Second
Description
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.
Time Frame
up to 28 days
Title
FVC, Forced Vital Capacity
Description
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.
Time Frame
up to 28 days
Title
FEV1/FVC%, the Ratio of FEV1 to FVC
Description
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.
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
Number of Cases With Antibiotics Therapy
Description
antibiotics therapy is the indicators of pulmonary infection
Time Frame
up to 28 days
Title
Number of Cases With Hospital Visit
Time Frame
up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Xiangyu, MD
Organizational Affiliation
Shanghai Tebth People's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
20979671
Citation
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.
Results Reference
derived
Learn more about this trial
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
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