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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJian-Xin Zhou

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

This study will include 220 adult (≥18 years) postoperative neurosurgical patients admitted for the first time to the ICUs of three centers: Beijing Tiantan Hospital, Beijing Shijitan Hospital, and Beijing Anzhen 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

220 Participants
are grouped into 1 trial group
Group A: Postoperative Neurosurgical ICU Patients

Trial outcomes

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.

Time frame
Within 28 days of ICU admission

Secondary outcomes

1

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

Changes in pulmonary microbiota composition and diversity, assessed using 16S rRNA gene sequencing and quantitative analysis, will be evaluated for their association with the occurrence of hospital-acquired pneumonia (HAP) during the ICU stay. Statistical models will be applied to determine correlations between microbiota alterations and HAP risk.

Time frame
Within 28 days of ICU admission
2

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

Ventilator-associated pneumonia (VAP) will be diagnosed according to the 2016 IDSA/ATS guidelines as pneumonia occurring 48 hours or more after endotracheal intubation or tracheostomy. The number and proportion of VAP cases occurring within 28 days of ICU admission will be calculated.

Time frame
Within 28 days of ICU admission
3

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

Changes in pulmonary microbiota composition and diversity, assessed using 16S rRNA gene sequencing and quantitative analysis, will be evaluated for their association with the occurrence of ventilator-associated pneumonia (VAP) during the ICU stay. Statistical models will be applied to determine correlations between microbiota alterations and VAP risk.

Time frame
Within 28 days of ICU admission

Other outcomes

Sponsors and contacts

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Jian-Xin Zhou

Lead sponsor

Capital Medical University

Sponsor institution

Capital Medical University

Collaborator