Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis

Effect of Bedside Flexible Bronchoscopy-Guided Airway Clearance on Lung Aeration in Mechanically Ventilated Patients With Atelectasis: A Multicenter Randomized Controlled Trial

The goal of this clinical trial is to learn whether bedside flexible bronchoscopy-guided airway clearance can improve lung aeration in adult patients who are receiving invasive mechanical ventilation and have atelectasis with a high airway secretion burden.

The main questions it aims to answer are:

Does bedside flexible bronchoscopy-guided airway clearance reduce the proportion of nonaerated lung tissue from baseline to day 5? Does this treatment improve other lung aeration measures, respiratory mechanics, arterial blood gas parameters, pulmonary infection score, ventilator-free days, intensive care unit length of stay, and safety outcomes?

Researchers will compare usual airway care plus bedside flexible bronchoscopy-guided airway clearance with usual airway care alone to see if bronchoscopy-guided airway clearance improves lung aeration and clinical outcomes.

Participants will be randomly assigned to one of two groups. Participants in the usual care group will receive standard airway management, which may include airway suctioning, postural drainage, humidification, chest physiotherapy, and other routine respiratory care. Participants in the bronchoscopy group will receive the same usual care, plus bedside flexible bronchoscopy-guided airway clearance when predefined criteria for high airway secretion burden are met.

Participants will have clinical assessments during the study, including chest imaging, respiratory mechanics measurements, arterial blood gas tests, pulmonary infection score assessment, and safety monitoring. The main assessment will compare quantitative chest computed tomography findings at baseline and day 5 to evaluate changes in nonaerated lung tissue.

Study Overview

• Status: Not yet recruiting
• Conditions: Mechanical Ventilation; Atelectasis
• Intervention / Treatment: Other: Usual Airway Care; Procedure: Flexible Bronchoscopy-Guided Airway Clearance

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengyuan Shen, MD; Phone Number: +8615996997839; Email: Smy0116tu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older
2. Receiving invasive mechanical ventilation for at least 48 hours
3. Presence of atelectasis confirmed by chest computed tomography, chest X-ray, or lung ultrasound
4. High airway secretion burden, defined as requiring airway suctioning at least twice per hour during the previous 8 hours
5. Written informed consent obtained from the participant or legally authorized representative

Exclusion Criteria:

1. Expected duration of artificial airway maintenance less than 5 days
2. Untreated tension pneumothorax Known or suspected aspiration
3. Active intrapulmonary hemorrhage
4. Severe dysfunction of other organs with expected short-term mortality within 7 days or need for palliative care
5. Any other condition judged by the medical team to make the participant unsuitable for the study
6. Informed consent not obtained

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Airway Care	Other: Usual Airway Care; Usual airway care may include airway suctioning, postural drainage, chest physiotherapy, mechanical airway clearance techniques, humidification and heating of inhaled gas, cuff pressure monitoring, and timely clearance of airway secretions according to routine clinical practice.
Experimental: Bronchoscopy-Guided Airway Clearance	Procedure: Flexible Bronchoscopy-Guided Airway Clearance; Bedside flexible bronchoscopy-guided airway clearance will be performed through the artificial airway in mechanically ventilated participants. The procedure will be used to inspect the tracheobronchial tree and remove retained airway secretions or mucus plugs by targeted suctioning. Small-volume saline lavage may be used when secretions are thick or difficult to remove. The intervention will be performed in addition to usual airway care when predefined criteria for high airway secretion burden are met. After the procedure, ventilator settings will be restored according to the study protocol and the participant's clinical condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change in CT-assessed Nonaerated Lung Percentage From Baseline to Day 5	Baseline to Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in CT-assessed Normally Aerated Lung Percentage From Baseline to Day 5		Baseline to Day 5, with chest CT performed within 24 hours of each time point
Change in static respiratory system compliance from baseline to Day 5	Static respiratory system compliance will be measured under controlled mechanical ventilation. The change from baseline to Day 5 will be calculated as the Day 5 value minus the baseline value.	Baseline to Day 5
Change in driving pressure from baseline to Day 5	Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure. The change from baseline to Day 5 will be calculated as the Day 5 value minus the baseline value.	Baseline and Day 5
Change in plateau pressure from baseline to Day 5	Plateau pressure will be recorded during mechanical ventilation. The change from baseline to Day 5 will be calculated as the Day 5 value minus the baseline value.	Baseline and Day 5
Change in PaO2/FiO2 ratio from baseline to Day 5		Baseline and Day 5
Ventilator-free days within 28 days after randomization	Ventilator-free days are defined as the number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization. Patients who die before Day 28 will be assigned zero ventilator-free days. Patients who remain on invasive mechanical ventilation for 28 days or longer will also be assigned zero ventilator-free days. For patients successfully liberated from invasive mechanical ventilation and alive at Day 28, ventilator-free days will be calculated as 28 minus the number of days receiving invasive mechanical ventilation.	From randomization to Day 28
All-cause mortality within 28 days after randomization	All-cause mortality will be defined as death from any cause occurring within 28 days after randomization.	From randomization to Day 28
Length of stay in the intensive care unit		From randomization to ICU discharge or death, assessed up to 28 days

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Ling Liu, PHD, Zhongda Hospital, School of Medicine, Southeast University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Atelectasis; Airway Secretion Retention
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: BRONCO-CLEAR Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No