Ventilator Associated PneumoniaNCT06511986
M-I/E for Preventing VAP in Post-neurosurgical Patients
An observational study of Ventilator Associated Pneumonia and Brain Injuries, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial summary
Ventilator-associated pneumonia (VAP) is a common infection in critically ill patients, especially those with acute brain injuries, leading to increased mortality and longer ICU stays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Brain Injuries, Mechanical Insufflation-exsufflation
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Post-neurosurgical adult patients receiving mechanical ventilation
Who may be able to join
- Post-neurosurgical adult patients
- >18years old
- Body mass index (BMI) <35kg/m2)
- Receiving mechanical ventilation
- With arterial blood catheter for continuous pressure measurement and/or ventricular catheter drainage for ICP measurement (only for study one)
Who cannot join
- ICP > 22cmH2O or evidence of increased ICP
- Hemodynamically unstable (SBP< 90 or > 160 mmHg; DBP < 50 or > 110 mmHg, using cardiovascular medicine to maintain pressure, or known cardiac failure)
- Patients with lung trauma, emphysema, bronchopleural fistula or risk of pneumothorax
- History of mechanical ventilation and pneumonia within 6 months before ICU admission
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, 100090
About this study
Official title: Impact of Mechanical Insufflation-Exsufflation on Ventilator-Associated Pneumonia in Post-Neurosurgical Patients: a Safety and Efficacy Study
Ventilator-associated pneumonia (VAP) is a common infection in critically ill patients, especially those with acute brain injuries, leading to increased mortality and longer ICU stays.
The mechanical insufflation/exsufflation (M-I/E) cough assist device improves outcomes in patients with neuromuscular disorders but its effects on brain-injured patients are largely unknown.
This study is conducted at a tertiary neurosurgical medical center and consists of two substudies. The prospective physiological study assessed the impact of M-I/E on hemodynamics and ICP in mechanically ventilated neurosurgical patients. The combined retrospective-prospective clinical study was performed to investigate the efficacy of M-I/E on occurence of VAP and other clinical outcomes.
- Medical subject headings
- Pneumonia, Ventilator-Associated, Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure
In study one, mean blood pressure will be recorded during the incremental pressure changes in the study one
Measured: during the process of physiological study, up to 2 hours
Heart rate
In study one, heart rate will be recorded during the incremental pressure changes in the study one
Measured: During the process of physiological study, up to 2 hours
Rate of ventilator associated pneumonia
In study two, ventilator associated pneumonia is defined as pneumonia occurring in patients who have been mechanically ventilated for at least 48 hours. Pneumonia was diagnosed by clinical features (e.g., cough, fever, pleuritic chest pain) and by lung imaging. To derived the diagnosis of pneumonia, patient electronical record, lab results, and images were extracted from the electronical system.
Measured: Within 7 days after the onset of mechanical of ventilation
Secondary outcomes (4)
Intracranial pressure
In study one, intracranial pressure will be recorded during the incremental pressure changes in the study one
Measured: During the process of physiological study, up to 2 hours
Length of stay in ICU
Days of ICU Stay
Measured: Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came first,through study completion, an average of 1 year
Length of hospital stay
Days of hospital stay
Measured: Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year
Days of receiving mechanical ventilation
The duration from the start of mechanical ventilation to the weaning off from ventilator
Measured: Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start4 Mar 2024
- Primary completion22 Jan 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies 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
- Other
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhonghua Shi, MD, PhD, Beijing Sanbo Brain Hospital
- Investigators
- Zhonghua Shi, PhD,MD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511986
- Sponsor's protocol ID
- VAP prevention
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang R, Zhang M, Zhang X, Liu Y, Li J, Wang H, Han S, Huang X, Shi Z. Safety and Efficacy of Mechanical Insufflation/Exsufflation Cough Assistance for Preventing Postoperative Pneumonia in Neurosurgical Patients: A Combined Physiological and Cohort Study. Neurocrit Care. 2026 Apr;44(2):587-596. doi: 10.1007/s12028-025-02386-y. Epub 2025 Sep 22.
PubMed 40983845
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mechanical Insufflation-Exsufflation on Ventilator-Associated Pneumonia in Post-Neurosurgical Patients: a Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT06511986
- Acronym / sponsor ID
- VAP prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 22 Jul 2024 (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.
Ventilator-associated pneumonia (VAP) is a common infection in critically ill patients, especially those with acute brain injuries, leading to increased mortality and longer ICU stays.
The mechanical insufflation/exsufflation (M-I/E) cough assist device improves outcomes in patients with neuromuscular disorders but its effects on brain-injured patients are largely unknown.
This study is conducted at a tertiary neurosurgical medical center and consists of two substudies. The prospective physiological study assessed the impact of M-I/E on hemodynamics and ICP in mechanically ventilated neurosurgical patients. The combined retrospective-prospective clinical study was performed to investigate the efficacy of M-I/E on occurence of VAP and other clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-neurosurgical adult patients receiving mechanical ventilation
Key inclusion criteria (5 listed)
- Post-neurosurgical adult patients
- >18years old
- Body mass index (BMI) <35kg/m2)
- Receiving mechanical ventilation
- With arterial blood catheter for continuous pressure measurement and/or ventricular catheter drainage for ICP measurement (only for study one)
Key exclusion criteria (4 listed)
- ICP > 22cmH2O or evidence of increased ICP
- Hemodynamically unstable (SBP< 90 or > 160 mmHg; DBP < 50 or > 110 mmHg, using cardiovascular medicine to maintain pressure, or known cardiac failure)
- Patients with lung trauma, emphysema, bronchopleural fistula or risk of pneumothorax
- History of mechanical ventilation and pneumonia within 6 months before ICU admission
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
Mean blood pressure
Time frame: during the process of physiological study, up to 2 hours
In study one, mean blood pressure will be recorded during the incremental pressure changes in the study one
Heart rate
Time frame: During the process of physiological study, up to 2 hours
In study one, heart rate will be recorded during the incremental pressure changes in the study one
Rate of ventilator associated pneumonia
Time frame: Within 7 days after the onset of mechanical of ventilation
In study two, ventilator associated pneumonia is defined as pneumonia occurring in patients who have been mechanically ventilated for at least 48 hours. Pneumonia was diagnosed by clinical features (e.g., cough, fever, pleuritic chest pain) and by lung imaging. To derived the diagnosis of pneumonia, patient electronical record, lab results, and images were extracted from the electronical system.
4 secondary outcomes
Intracranial pressure
Time frame: During the process of physiological study, up to 2 hours
Length of stay in ICU
Time frame: Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came first,through study completion, an average of 1 year
Length of hospital stay
Time frame: Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year
Days of receiving mechanical ventilation
Time frame: Patients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 40983845Zhang R, Zhang M, Zhang X, Liu Y, Li J, Wang H, Han S, Huang X, Shi Z. Safety and Efficacy of Mechanical Insufflation/Exsufflation Cough Assistance for Preventing Postoperative Pneumonia in Neurosurgical Patients: A Combined Physiological and Cohort Study. Neurocrit Care. 2026 Apr;44(2):587-596. doi: 10.1007/s12028-025-02386-y. Epub 2025 Sep 22.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zhonghua Shi, PhD,MD principal investigator
Capital Medical University
1 site 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 and Brain Injuries, run by Beijing Sanbo Brain Hospital at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood pressure (time frame: during the process of physiological study, up to 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06511986, which also lists 1 linked publication.
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 19 Mar 2025.