CompletedNot Applicable

M-I/E for Preventing VAP in Post-neurosurgical Patients

China210 participantsStarted 2024-03-04

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean blood pressure

Timeframe: during the process of physiological study, up to 2 hours

Heart rate

Timeframe: During the process of physiological study, up to 2 hours

Rate of ventilator associated pneumonia

Timeframe: Within 7 days after the onset of mechanical of ventilation

Trial details

NCT IDNCT06511986

SponsorBeijing Sanbo Brain Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-22

View on ClinicalTrials.gov More Ventilator Associated Pneumonia trials