Pulmonary DiseaseNCT00881335
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
A study testing flutter mucus clearance device in people with Pulmonary Disease, run by Tongji University.
Trial summary
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium. Read more about this study
- Who is it for?
- Ages 85 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- flutter mucus clearance device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 85 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- available to perform the device, the elders in geracomium
- male and female
- aging 85 years or more
Who cannot join
- not available to perform the procedure
- untreated pneumothorax
- diffusion interstitial lung disease
- acute coronary syndrome
- third stage hypertension
- advanced cancer
Show all 9Show fewer
- severe heart, liver, renal, blood system and endocrine system dysfunction
- noninvasive mechanical ventilation
- active hemoptysis
About this study
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.
Read the 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.
- Conditions
- Pulmonary Disease
- Being tested
- flutter mucus clearance device
- Keywords
- geriatric, pulmonary disease, flutter, sputum, physical therapy techniques
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flutter mucus clearance deviceDevice
five minutes every sessions, three sessions per day
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| intervention | Experimental | Intervention group were given flutter valve mucus clearance devices to do pulmonary function exercise Receives: Device: flutter mucus clearance device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
Measured: up to 28 days
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.
Measured: up to 28 days
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.
Measured: up to 28 days
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.
Measured: up to 28 days
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.
Measured: up to 28 days
Secondary outcomes (2)
Number of Cases With Antibiotics Therapy
antibiotics therapy is the indicators of pulmonary infection
Measured: up to 28 days
Number of Cases With Hospital Visit
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Xiangyu, Tongji University
- Investigators
- Zhang Xiangyu, MD, Principal investigator, Shanghai Tebth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881335
- Sponsor's protocol ID
- SHDC12007211-O
- Status last verified
- Jun 2012
- First submitted
- 14 Apr 2009
- Last updated
- 29 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20979671
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
- ClinicalTrials.gov ID
- NCT00881335
- Acronym / sponsor ID
- SHDC12007211-O
- Conditions
- Pulmonary Disease
- Keywords
- geriatric, pulmonary disease, flutter, sputum, physical therapy techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Apr 2009 (estimated)
- Results
- Posted 20 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| intervention | Experimental | Device: flutter mucus clearance deviceIntervention group were given flutter valve mucus clearance devices to do pulmonary function exercise |
Who may qualify
- Ages
- 85 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- available to perform the device, the elders in geracomium
- male and female
- aging 85 years or more
Key exclusion criteria (9 listed)
- not available to perform the procedure
- untreated pneumothorax
- diffusion interstitial lung disease
- acute coronary syndrome
- third stage hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flutter mucus clearance devicefive minutes every sessions, three sessions per day | Device | intervention |
Primary outcome
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
Time frame: up to 28 days
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.
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.
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.
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.
2 secondary outcomes
Number of Cases With Antibiotics Therapy
Time frame: up to 28 days
Number of Cases With Hospital Visit
Time frame: up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20979671Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Xiangyu, MD principal investigator
Shanghai Tebth People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing flutter mucus clearance device in people with Pulmonary Disease, run by Tongji University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher) (time frame: up to 28 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.