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Association Between Changes in Pulmonary Microbiota and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways: A Prospective Observational Cohort Study

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Shijitan Hospital
RECRUITING
Beijing
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Jian-Xin Zhou, Professor
zhoujx.cn@icloud.com
8610 6392 6666
Backup
Yi-Ran Li, MD
liuyirandou@163.com
8613621234800
Time Frame
Start Date: 2025-08-30
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 220
Treatments
Postoperative Neurosurgical ICU Patients
This cohort includes adult patients admitted to the ICU for the first time following neurosurgical procedures (including brain tumor surgery, subarachnoid hemorrhage surgery, and traumatic brain injury surgery) and expected to receive invasive mechanical ventilation for more than 24 hours. Patients will undergo serial collection of tracheal aspirate samples to assess the dynamic changes in the pulmonary microbiota. No therapeutic intervention is applied; this is a prospective observational cohort study.
Related Therapeutic Areas
Sponsors
Collaborators: Capital Medical University
Leads: Jian-Xin Zhou

This content was sourced from clinicaltrials.gov