NCT07594379

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

AtelectasisMechanical VentilationAirway Secretion Retention

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Nonaerated Lung Tissue From Baseline to Day 5

    Baseline to Day 5

Secondary Outcomes (3)

  • Percentage Change in Normally Aerated Lung Tissue From Baseline to Day 5

    Baseline to Day 5, with chest CT performed within 24 hours of each time point

  • Change in Respiratory Mechanics From Baseline to Day 5

    Baseline to Day 5

  • Change in Arterial Blood Gas Parameters From Baseline to Day 5

    Change in Arterial Blood Gas Parameters From Baseline to Day 5

Study Arms (2)

Usual Airway Care

ACTIVE COMPARATOR
Other: Usual Airway Care

Bronchoscopy-Guided Airway Clearance

EXPERIMENTAL
Procedure: Flexible Bronchoscopy-Guided Airway Clearance

Interventions

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.

Bronchoscopy-Guided Airway Clearance

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.

Usual Airway Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Expected duration of artificial airway maintenance less than 5 days
  • Untreated tension pneumothorax 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Ling Liu, PHD

    Zhongda Hospital, School of Medicine, Southeast University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengyuan Shen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 18, 2026

Record last verified: 2026-05