AtelectasisNCT07594379
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
A study testing Flexible Bronchoscopy-Guided Airway Clearance and Usual Airway Care in people with Atelectasis and Mechanical Ventilation, run by Southeast University, China at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis, Mechanical Ventilation
- What is being tested?
- Flexible Bronchoscopy-Guided Airway Clearance and Usual Airway Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2026to 1 Jun 2028
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Receiving invasive mechanical ventilation for at least 48 hours
- Presence of atelectasis confirmed by chest computed tomography, chest X-ray, or lung ultrasound
- High airway secretion burden, defined as requiring airway suctioning at least twice per hour during the previous 8 hours
- Written informed consent obtained from the participant or legally authorized representative
Who cannot join
- Expected duration of artificial airway maintenance less than 5 days
- Untreated tension pneumothorax
- Large pleural effusions requiring thoracentesis.
- Known or suspected aspiration
- Active intrapulmonary hemorrhage
- Severe dysfunction of other organs with expected short-term mortality within 7 days or need for palliative care
- Any other condition judged by the medical team to make the participant unsuitable for the study
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
mengyuan shen, +86-15996997839, Smy0116tu@163.com
About this study
Official title: 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:
Read more
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.
- Conditions
- Atelectasis, Mechanical Ventilation
- Being tested
- Flexible Bronchoscopy-Guided Airway Clearance, Usual Airway Care
- Keywords
- Atelectasis, Mechanical Ventilation, Airway Secretion Retention
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Bronchoscopy-Guided Airway ClearanceProcedure or surgery
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.
Usual Airway CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Airway Care | Active comparator | Not described Receives: Other: Usual Airway Care |
| Bronchoscopy-Guided Airway Clearance | Experimental | Not described Receives: Procedure: Flexible Bronchoscopy-Guided Airway Clearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in CT-assessed Nonaerated Lung Percentage From Baseline to Day 5
Measured: Baseline to Day 5
Secondary outcomes (8)
Percent Change in CT-assessed Normally Aerated Lung Percentage From Baseline to Day 5
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 5
Change in PaO2/FiO2 ratio from baseline to Day 5
Measured: 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.
Measured: 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.
Measured: From randomization to Day 28
Length of stay in the intensive care unit
Measured: From randomization to ICU discharge or death, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start5 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Ling Liu, PHD, Principal investigator, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594379
- Sponsor's protocol ID
- BRONCO-CLEAR Trial
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided