Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

NCT ID: NCT06393257

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiectasis Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized into one of the two groups. No cross-over of the study group will be made
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oscillation and Lung Expansion

Group Type EXPERIMENTAL

Oscillation and Lung Expansion

Intervention Type DEVICE

A novel airway clearance technology

Anti-infective therapy

Intervention Type DRUG

Antibiotics were used in these patients.

Mucolytic

Intervention Type DRUG

Mucolytics were used in these patients.

postural drainage

Group Type ACTIVE_COMPARATOR

Postural drainage

Intervention Type 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

Intervention Type DRUG

Antibiotics were used in these patients.

Mucolytic

Intervention Type DRUG

Mucolytics were used in these patients.

Interventions

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Oscillation and Lung Expansion

A novel airway clearance technology

Intervention Type DEVICE

Postural drainage

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.

Intervention Type BEHAVIORAL

Anti-infective therapy

Antibiotics were used in these patients.

Intervention Type DRUG

Mucolytic

Mucolytics were used in these patients.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with acute exacerbation of bronchiectasis

Exclusion Criteria

* Haemoptysis greater than 50ml
* state of endangerment
* pneumothorax
* Lung surgery history within 6 months
* Severe heart, brain and nervous system diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role lead

Responsible Party

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Jin-Fu Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Fu Xu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Jin-Fu Xu, PhD

Role: CONTACT

+8613321922898

Facility Contacts

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Jie-ming Qu, PhD

Role: primary

Jin-Fu Xu, PhD

Role: primary

+8613321922898

Min Zhang, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23945301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26882271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32622820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29326318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28952156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34537448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31362061 (View on PubMed)

Other Identifiers

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20230901

Identifier Type: -

Identifier Source: org_study_id

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