Pulmonary Disease, Chronic ObstructiveNCT00816881
Application and Generalization of Flutter Mucus Clearance Device
A study testing flutter mucus clearance device in people with Pulmonary Disease, Chronic Obstructive, run by Tongji University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- 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
- 356 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonary department: available to perform the device, in-hospital patients
- Male and female
- Age: 45 - 85 years
- Chronic bronchitis, COPD
- Thoracic surgery department and surgical department (upper abdomen):
- Patients with endotracheal intubation of general anesthesia
- Age: 40-75 years
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 10Show fewer
- Severe heart, liver, renal , blood system and endocrine system dysfunction
- Noninvasive mechanical ventilation more than 6 hrs per day
- Patients with invasive ventilation and cannot weaning and extubation within 48 hours
- Active hemoptysis
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.
Read the detailed description
Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- flutter mucus clearance device
- Keywords
- Pulmonary Disease, Chronic Obstructive, flutter, airway clearance, sputum, Physical Therapy Techniques
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 session, four sessions per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | flutter mucus clearance device Receives: Device: flutter mucus clearance device |
| 2 | No intervention | Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days
Measured: one year
Secondary outcomes (1)
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 356 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 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816881
- Sponsor's protocol ID
- SHDC12007211
- Status last verified
- Jun 2012
- First submitted
- 2 Jan 2009
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.
PubMed 25534580
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Generalization of Flutter Mucus Clearance Device
- ClinicalTrials.gov ID
- NCT00816881
- Acronym / sponsor ID
- SHDC12007211
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, flutter, airway clearance, sputum, Physical Therapy Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Jan 2009 (estimated)
- Results
- Not posted in the source record
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.
Detailed description
Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control 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 |
|---|---|---|
| 1 | Experimental | Device: flutter mucus clearance deviceflutter mucus clearance device |
| 2 | No intervention | –Observation |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pulmonary department: available to perform the device, in-hospital patients
- Thoracic surgery department and surgical department (upper abdomen):
Key exclusion criteria (10 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 session, four sessions per day | Device | 1 |
Primary outcome
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days
Time frame: one year
1 secondary outcome
rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
- Derived from this study: PubMed 25534580Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.
Related trials for Pulmonary Disease, Chronic Obstructive
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flutter mucus clearance device in people with Pulmonary Disease, Chronic Obstructive, run by Tongji University at 1 site in China.
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 7 inclusion and 10 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days (time frame: one year). 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 NCT00816881, 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 22 Jun 2012.