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Clinical Trials in China / NCT07129174
Recruiting Observational

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

NCT07129174 · tracked via the Priya Life Science China tracker
Sponsor
Jian-Xin Zhou
Phase
Observational
Started
2025-08-30
Last updated
2026-05-22

Condition(s) studied

Ventilator-Associated Pneumonia (VAP)Intensive Care Unit (ICU) PatientsMicrobiome Dysbiosis

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients must meet all of the following conditions to be eligible for inclusion: 1. First admission to the Intensive Care Unit (ICU). 2. Assessed by an ICU specialist as expected to require artificial airway support (e.g., mechanical ventilation) for more than 24 hours. 3. Neurosurgical patients. Postoperative neurosurgical patients are defined in this study as those who have undergone surgery for: brain tumors, Subarachnoid hemorrhage, Traumatic brain injury Exclusion Criteria: * Patients meeting any of the following criteria will be excluded: 1. Age under 18 years 2. Pregnancy 3. Pre-existing spinal cord injury 4. History of chronic pulmonary diseases, including: Chronic bronchitis, Chronic obstructive pulmonary disease (COPD), Bronchial asthma, Bronchiectasis, Interstitial lung disease, Pleural effusion 5. Pre-existing immunosuppressive conditions, including: Systemic immunomodulatory therapy, Chemotherapy, HIV infection, Other congenital or acquired immunodeficiency disorders 6. Receipt of systemic antimicrobial therapy within the past 3 months 7. Diagnosis of primary lung cancer or lung metastases from other tumors 8. History of partial lung resection for any reason

Primary outcome measure(s)

  • Incidence of Hospital-Acquired Pneumonia (HAP) Within 28 Days of ICU Admission — Within 28 days of ICU admission
    Hospital-acquired pneumonia (HAP) will be diagnosed according to the 2016 IDSA/ATS guidelines. The number of HAP cases occurring within 28 days of ICU admission will be recorded. This outcome will be used to evaluate whether alterations in the pulmonary microbiota are associated with the risk of nosocomial pneumonia and may inform empiric antibiotic strategies in the ICU setting.

Trial sites (3)

FacilityCityRegionStatus
Beijing Shijitan Hospital Beijing Beijing Municipality Recruiting
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality Recruiting

More Jian-Xin Zhou trials in China

Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments Recruiting
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation Starting soon
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation Starting soon
Comparison of Physiological Effects of Two Types of High-Flow Oxygen Therapy in Tracheostomized Patients Starting soon
Comparison of Physiological Effects of Two High-Flow Tracheal Oxygen Versus T-Piece During Spontaneous Breathing Trials Recruiting

Other trials for the same condition

Inhaled Colistin to Prevent Ventilator-Associated Pneumonia in Patients With Acute Brain Injury Recruiting
Colistin Methanesulfonate Sodium Inhalation for Prophylaxis of Ventilator-Associated Pneumonia (CIVAP): A Prospective, Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial Recruiting
Dynamic Airway Resistance & ML: Guide Sputum Suction in Ventilated Patients Recruiting
Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07129174 on ClinicalTrials.gov ↗ ← All trials in China