M-I/E for Preventing VAP in Post-neurosurgical Patients
- Conditions
- Brain InjuriesVentilator Associated PneumoniaMechanical Insufflation-exsufflation
- Registration Number
- NCT06511986
- Lead Sponsor
- Beijing Sanbo Brain Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of ventilator associated pneumonia 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.
Heart rate 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
Mean blood pressure 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
- Secondary Outcome Measures
Name Time Method Intracranial pressure During the process of physiological study, up to 2 hours In study one, intracranial pressure will be recorded during the incremental pressure changes in the study one
Length of stay in ICU 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 Days of ICU Stay
Length of hospital stay 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 hospital stay
Days of receiving mechanical ventilation 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 The duration from the start of mechanical ventilation to the weaning off from ventilator
Trial Locations
- Locations (1)
Beijing Sanbo Brain Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China