Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

Not Applicable

Recruiting

• Conditions: Bronchiectasis Adult
• Interventions: Behavioral: Postural drainage; Device: Oscillation and Lung Expansion; Drug: Anti-infective therapy; Drug: Mucolytic

• Registration Number: NCT06393257
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-21
• Study First Submitted QC: 2024-04-27
• Last Update Submitted: 2024-04-27
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-09
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oscillation and Lung Expansion	Anti-infective therapy	-
Oscillation and Lung Expansion	Mucolytic	-
postural drainage	Postural drainage	-
postural drainage	Anti-infective therapy	-
postural drainage	Mucolytic	-
Oscillation and Lung Expansion	Oscillation and Lung Expansion	-

Primary Outcome Measures

Name	Time	Method
sputum volume in 24h	2 weeks

Secondary Outcome Measures

Name	Time	Method
Bronchiectasis exacerbation and symptom tool	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge	BEST score
Quality of life questionnaire-bronchiectasis	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge	Qol-B score
Leicester Cough Questionnaire	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge	LCQ score
Bronchiectasis Health Questionnaire	Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge	BHQ score
Time to the first bronchiectasis exacerbation since randomization	Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge	Time to the first bronchiectasis exacerbation since randomization

Trial Locations

Locations (3)

The Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai pulmonary hospital; 🇨🇳 Shanghai, Shanghai, China

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China