Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways

Recruiting now

Conditions studied: Ventilator-Associated Pneumonia (VAP), Intensive Care Unit (ICU) Patients, Microbiome Dysbiosis

In brief

After neurosurgery, many patients need to stay in the intensive care unit (ICU) and use a breathing machine (mechanical ventilation) because of issues like decreased consciousness, weak breathing, or poor airway protection. During this period, the natural balance of bacteria in the lungs-known as the lung microbiota-can be disturbed by surgery, antibiotics, and airway procedures. This may reduce healthy bacteria and allow harmful bacteria to grow, increasing the risk of lung infections such as ventilator-associated pneumonia (VAP). This study will follow 220 postoperative neurosurgical ICU patients at three centers: Beijing Tiantan Hospital, Beijing Shijitan Hospital, and Beijing Anzhen Hospital from August 2025 to August 2026. These patients will include those undergoing surgery for brain tumors, brain hemorrhage, or traumatic brain injury. Airway secretion samples (tracheal aspirates) will be collected shortly after surgery and at several subsequent time points to assess how lung bacteria change over time while patients are using a breathing machine. Using advanced laboratory methods, the investigators will measure both the amount and types of bacteria in the lungs. The aim is to determine how these changes are related to patient outcomes, such as the occurrence of lung infections. The results of this study may contribute to earlier detection of lung infections and the development of personalized treatment plans to improve recovery in ICU patients after neurosurgery.

Key facts

Study ID: NCT07129174
Run by: Jian-Xin Zhou
People needed: 220
Starts: 2025-08-30
Expected to finish: 2026-08-30
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must meet all of the following conditions to be eligible for inclusion:
First admission to the Intensive Care Unit (ICU).
Assessed by an ICU specialist as expected to require artificial airway support (e.g., mechanical ventilation) for more than 24 hours.
Neurosurgical patients. Postoperative neurosurgical patients are defined in this study as those who have undergone surgery for: brain tumors, Subarachnoid hemorrhage, Traumatic brain injury

You may not qualify if…

Patients meeting any of the following criteria will be excluded:
Age under 18 years
Pregnancy
Pre-existing spinal cord injury
History of chronic pulmonary diseases, including: Chronic bronchitis, Chronic obstructive pulmonary disease (COPD), Bronchial asthma, Bronchiectasis, Interstitial lung disease, Pleural effusion
Pre-existing immunosuppressive conditions, including: Systemic immunomodulatory therapy, Chemotherapy, HIV infection, Other congenital or acquired immunodeficiency disorders
Receipt of systemic antimicrobial therapy within the past 3 months
Diagnosis of primary lung cancer or lung metastases from other tumors
History of partial lung resection for any reason

Where it is running

Beijing Shijitan Hospital — Beijing, Beijing Municipality, China (enrolling)
Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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