Actively Recruiting
Association Between Changes in Pulmonary Microbiota and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways: A Prospective Observational Cohort Study
Led by Jian-Xin Zhou · Updated on 2026-05-22
220
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
Sponsors
J
Jian-Xin Zhou
Lead Sponsor
C
Capital Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the lung bacteria change over time in adult neurosurgical patients who need mechanical ventilation in the intensive care unit (ICU). These patients often require breathing support after surgery for brain tumors, brain hemorrhage, or traumatic brain injury. The study aims to understand how disruptions in the lung microbiota caused by surgery, antibiotics, and airway procedures might increase the risk of lung infections like ventilator-associated pneumonia (VAP). This prospective observational study will follow 220 postoperative neurosurgical ICU patients at three hospitals from August 2025 to August 2026. Researchers will collect airway secretion samples (tracheal aspirates) shortly after surgery and at multiple later time points. Using advanced lab methods such as 16S rRNA gene sequencing and droplet digital PCR, they will measure the amount and types of bacteria in the lungs to track microbial changes over time without applying any treatment intervention. Participants will be monitored for clinical outcomes including the occurrence of hospital-acquired and ventilator-associated pneumonia within 28 days of ICU admission. The study will collect detailed clinical data along with microbial profiles to explore links between lung bacteria changes and patient recovery, length of ICU stay, and ventilation duration. This information may help develop early detection methods and personalized treatment strategies for lung infections in neurosurgical ICU patients.
CONDITIONS
Brief Title
Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First admission to the Intensive Care Unit (ICU)
- Expected to require mechanical ventilation for more than 24 hours
- Adult neurosurgical patients who have had surgery for brain tumors, subarachnoid hemorrhage, or traumatic brain injury
You will not qualify if you...
- Under 18 years of age
- Pregnant
- Pre-existing spinal cord injury
- Chronic pulmonary diseases such as chronic bronchitis, COPD, asthma, bronchiectasis, interstitial lung disease, or pleural effusion
- Pre-existing immunosuppressive conditions including systemic immunomodulatory therapy, chemotherapy, HIV infection, or other immunodeficiency disorders
- Received systemic antimicrobial therapy within the past 3 months
- Diagnosis of primary lung cancer or lung metastases
- History of partial lung resection for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days during ICU stay
Participants who have undergone neurosurgical procedures and are admitted to the ICU are observed to assess changes in their pulmonary microbiota through serial tracheal aspirate collections, without receiving any therapeutic intervention.
Serial sample collections during ICU stay
Trial Site Locations
Total: 3 locations
1
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
3
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101100
Actively Recruiting
Research Team
J
Jian-Xin Zhou, Professor
Y
Yi-Ran Li, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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