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The goal of this prospective randomized controlled trial is to explore the efficacy and safety of Oscillation and Lung Expansion-a airway clearance technology-in bronchiectasis. Participants will receive Oscillation and Lung Expansion or postural drainage randomly in this study. and the symptom, quality of life scores and amount of expectoration will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oscillation and Lung Expansion | Experimental |
| |
| postural drainage | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oscillation and Lung Expansion | Device | A novel airway clearance technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| sputum volume in 24h | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchiectasis exacerbation and symptom tool | BEST score | Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge |
| Quality of life questionnaire-bronchiectasis | Qol-B score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin-Fu Xu, PhD | Contact | +8613321922898 | jfxucn@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin-Fu Xu, PhD | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23945301 | Background | Zhou YM, Wang C, Yao WZ, Chen P, Kang J, Huang SG, Chen BY, Wang CZ, Ni DT, Liu SM, Wang XP, Wang DL, Lu JC, Zheng JP, Zhong NS, Ran PX. [The prevalence and risk factors of bronchiectasis in residents aged 40 years old and above in seven cities in China]. Zhonghua Nei Ke Za Zhi. 2013 May;52(5):379-82. Chinese. | |
| 26882271 | Background |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015916 | Drainage, Postural |
| D005100 | Expectorants |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Patients will be randomized into one of the two groups. No cross-over of the study group will be made
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| Postural drainage | Behavioral | A type of physical therapy used to treat respiratory diseases by changing the patient's body position so that sputum is drained down the respiratory tract so that it can be more easily expelled from the body. |
|
| Anti-infective therapy | Drug | Antibiotics were used in these patients. |
|
| Mucolytic | Drug | Mucolytics were used in these patients. |
|
| Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge |
| Leicester Cough Questionnaire | LCQ score | Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge |
| Bronchiectasis Health Questionnaire | BHQ score | Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge |
| Time to the first bronchiectasis exacerbation since randomization | Time to the first bronchiectasis exacerbation since randomization | Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge |
| Shanghai pulmonary hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| The Shanghai First People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| Lin JL, Xu JF, Qu JM. Bronchiectasis in China. Ann Am Thorac Soc. 2016 May;13(5):609-16. doi: 10.1513/AnnalsATS.201511-740PS. |
| 32622820 | Background | Basavaraj A, Choate R, Addrizzo-Harris D, Aksamit TR, Barker A, Daley CL, Anne Daniels ML, Eden E, DiMango A, Fennelly K, Griffith DE, Johnson MM, Knowles MR, Metersky ML, Noone PG, O'Donnell AE, Olivier KN, Salathe MA, Schmid A, Thomashow B, Tino G, Winthrop KL. Airway Clearance Techniques in Bronchiectasis: Analysis From the United States Bronchiectasis and Non-TB Mycobacteria Research Registry. Chest. 2020 Oct;158(4):1376-1384. doi: 10.1016/j.chest.2020.06.050. Epub 2020 Jul 3. |
| 29326318 | Background | Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan. |
| 28952156 | Background | Lee AL, Burge AT, Holland AE. Positive expiratory pressure therapy versus other airway clearance techniques for bronchiectasis. Cochrane Database Syst Rev. 2017 Sep 27;9(9):CD011699. doi: 10.1002/14651858.CD011699.pub2. |
| 34537448 | Background | Liu Y, Lu HW, Gu SY, Wang WW, Ge J, Jie ZJ, Jia JG, Gao ZT, Li J, Shi JY, Liang S, Cheng KB, Bai JW, Qu JM, Xu JF. Bronchoscopic airway clearance therapy for acute exacerbations of bronchiectasis. EBioMedicine. 2021 Oct;72:103587. doi: 10.1016/j.ebiom.2021.103587. Epub 2021 Sep 16. |
| 31362061 | Background | Huynh TT, Liesching TN, Cereda M, Lei Y, Frazer MJ, Nahouraii MR, Diette GB. Efficacy of Oscillation and Lung Expansion in Reducing Postoperative Pulmonary Complication. J Am Coll Surg. 2019 Nov;229(5):458-466.e1. doi: 10.1016/j.jamcollsurg.2019.06.004. Epub 2019 Jul 27. |
| D012138 |
| Respiratory Therapy |
| D019141 | Respiratory System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |