Ventilator-Associated Pneumonia (VAP)NCT07129174
Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways
An observational study of Ventilator-Associated Pneumonia (VAP) and Intensive Care Unit (ICU) Patients, run by Jian-Xin Zhou at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Associated Pneumonia (VAP), Intensive Care Unit (ICU) Patients, Microbiome Dysbiosis
- How many people
- 220 participants
- Where
- 3 sitesChina
- Study dates
- 30 Aug 2025to 30 Aug 2026
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
Jian-Xin Zhou, professor, 8610 6392 6666, zhoujx.cn@icloud.com
Yi-Ran Liu, 8613621234800, liuyirandou@163.com
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Yu-Mei Wang, 8618515850267, wymzone5207@163.com
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
Lin-Lin Zhang, 8617611757717, abluelemon@163.com
About this study
Official title: Association Between Changes in Pulmonary Microbiota and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways: A Prospective Observational Cohort Study
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.
Read more
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.
Read the detailed description
Postoperative neurosurgical patients represent a unique and high-risk population in the ICU, often requiring prolonged invasive mechanical ventilation due to impaired consciousness and respiratory function. During this critical period, multiple factors-including surgical trauma, antibiotic administration, and airway manipulation-can disrupt the pulmonary microbiota, potentially leading to dysbiosis characterized by reduced microbial diversity and overgrowth of opportunistic pathogens.
Emerging evidence suggests that alterations in the lung microbiota may play a key role in the development of respiratory infections, such as ventilator-associated pneumonia (VAP), and could influence the overall clinical trajectory of ICU patients. However, current knowledge regarding the temporal dynamics of the lung microbiome in neurosurgical patients is limited, and its potential as a predictive biomarker for infection risk or recovery remains unexplored.
This prospective observational cohort study is designed to systematically characterize the succession patterns of the pulmonary microbiota in adult neurosurgical patients requiring mechanical ventilation. By integrating microbial profiling with clinical data, the study aims to elucidate the relationship between microbiota changes and patient outcomes, including infection incidence, length of ICU stay, and duration of ventilation.
High-resolution microbial analysis using 16S rRNA gene sequencing and quantitative techniques (e.g., droplet digital PCR) will allow for precise tracking of microbial shifts over time. These findings may provide new perspectives on host-microbiota interactions under ICU conditions and support the development of early warning indicators for infection, as well as inform personalized antimicrobial and ventilation strategies in postoperative care.
Ultimately, the study seeks to improve understanding of lung microbiome evolution in response to surgical and critical care interventions and to identify clinically relevant microbial patterns that may serve as novel prognostic tools in neurosurgical ICU populations.
- Conditions
- Ventilator-Associated Pneumonia (VAP), Intensive Care Unit (ICU) Patients, Microbiome Dysbiosis
- Keywords
- Ventilator-Associated Pneumonia (VAP), Intensive care unit (ICU), Pulmonary Microbiota
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 28 days of ICU admission
Secondary outcomes (3)
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.
Measured: Within 28 days of ICU admission
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.
Measured: Within 28 days of ICU admission
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.
Measured: Within 28 days of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start30 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated Pneumonia (VAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Jian-Xin Zhou
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University
- Responsible party
- Sponsor-investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129174
- Sponsor's protocol ID
- IIT2025-058-002
- Status last verified
- May 2026
- First submitted
- 2 Aug 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Changes in Pulmonary Microbiota and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07129174
- Acronym / sponsor ID
- IIT2025-058-002
- Conditions
- Ventilator-Associated Pneumonia (VAP), Intensive Care Unit (ICU) Patients, Microbiome Dysbiosis
- Keywords
- Ventilator-Associated Pneumonia (VAP), Intensive care unit (ICU), Pulmonary Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Collaborators
- Capital Medical University
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postoperative neurosurgical patients represent a unique and high-risk population in the ICU, often requiring prolonged invasive mechanical ventilation due to impaired consciousness and respiratory function. During this critical period, multiple factors-including surgical trauma, antibiotic administration, and airway manipulation-can disrupt the pulmonary microbiota, potentially leading to dysbiosis characterized by reduced microbial diversity and overgrowth of opportunistic pathogens.
Emerging evidence suggests that alterations in the lung microbiota may play a key role in the development of respiratory infections, such as ventilator-associated pneumonia (VAP), and could influence the overall clinical trajectory of ICU patients. However, current knowledge regarding the temporal dynamics of the lung microbiome in neurosurgical patients is limited, and its potential as a predictive biomarker for infection risk or recovery remains unexplored.
This prospective observational cohort study is designed to systematically characterize the succession patterns of the pulmonary microbiota in adult neurosurgical patients requiring mechanical ventilation. By integrating microbial profiling with clinical data, the study aims to elucidate the relationship between microbiota changes and patient outcomes, including infection incidence, length of ICU stay, and duration of ventilation.
High-resolution microbial analysis using 16S rRNA gene sequencing and quantitative techniques (e.g., droplet digital PCR) will allow for precise tracking of microbial shifts over time. These findings may provide new perspectives on host-microbiota interactions under ICU conditions and support the development of early warning indicators for infection, as well as inform personalized antimicrobial and ventilation strategies in postoperative care.
Ultimately, the study seeks to improve understanding of lung microbiome evolution in response to surgical and critical care interventions and to identify clinically relevant microbial patterns that may serve as novel prognostic tools in neurosurgical ICU populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- Patients must meet all of the following conditions to be eligible for inclusion:
Key exclusion criteria (9 listed)
- Patients meeting any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Hospital-Acquired Pneumonia (HAP) Within 28 Days of ICU Admission
Time frame: 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.
3 secondary outcomes
Association Between Pulmonary Microbiota Alterations and Risk of Hospital-Acquired Pneumonia
Time frame: Within 28 days of ICU admission
Incidence of Ventilator-Associated Pneumonia (VAP) Within 28 Days of ICU Admission
Time frame: Within 28 days of ICU admission
Association Between Pulmonary Microbiota Alterations and Risk of Ventilator-Associated Pneumonia
Time frame: Within 28 days of ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Related trials for Ventilator-Associated Pneumonia (VAP)
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
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Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
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Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
Ventilator Associated Bacterial Pneumonia (VABP), Critical Illness
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
Ventilator Associated Pneumonia ( VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian-Xin Zhou, MD, PhD principal investigator
Capital Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Associated Pneumonia (VAP) and Intensive Care Unit (ICU) Patients, run by Jian-Xin Zhou at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, Professor (8610 6392 6666, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hospital-Acquired Pneumonia (HAP) Within 28 Days of ICU Admission (time frame: Within 28 days of ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.