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

NCT07129174 | Not Yet Recruiting DMC

• 1 other identifier: IIT2025-058-002
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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 Beijing Tiantan Hospital and Beijing Shijitan 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.

Conditions

Ventilator-Associated Pneumonia (VAP); Intensive Care Unit (ICU) Patients; Microbiome Dysbiosis

Keywords

Ventilator-Associated Pneumonia (VAP); Intensive care unit (ICU); Pulmonary Microbiota

Outcome Measures

Primary Outcomes (1)

• Incidence of Hospital-Acquired Pneumonia (HAP) 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.

  Within 28 days of ICU admission

Secondary Outcomes (3)

• Association Between Pulmonary Microbiota Alterations and Risk of Hospital-Acquired Pneumonia

  Within 28 days of ICU admission

• Incidence of Ventilator-Associated Pneumonia (VAP) Within 28 Days of ICU Admission

  Within 28 days of ICU admission

• Association Between Pulmonary Microbiota Alterations and Risk of Ventilator-Associated Pneumonia

  Within 28 days of ICU admission

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include 220 adult (≥18 years) postoperative neurosurgical patients admitted for the first time to the ICUs of Beijing Tiantan Hospital and Beijing Shijitan Hospital between August 2025 and August 2026. Eligible patients will have undergone brain tumor surgery, subarachnoid hemorrhage surgery, or traumatic brain injury surgery and be expected to require artificial airway support for more than 24 hours. Inclusion and exclusion criteria will be applied to ensure a consistent, well-defined high-risk ICU population for evaluating clinical outcomes and associated factors.

You may qualify if:

• 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

Sponsors & Collaborators

• Jian-Xin Zhou: lead
• Capital Medical University: collaborator

Study Sites (1)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jian-Xin Zhou, MD, PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD, PhD

CONTACT

8610 6392 6666; zhoujx.cn@icloud.com

Yi-Ran Li, MD

CONTACT

8613621234800; liuyirandou@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 19, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)