Impact of Mechanical Insufflation-Exsufflation on Ventilator-Associated Pneumonia in Post-Neurosurgical Patients: a Safety and Efficacy Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ventilator Associated Pneumonia
- Sponsor
- Beijing Sanbo Brain Hospital
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Rate of ventilator associated pneumonia
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Zhonghua Shi, MD, PhD
vice president of dept. ICU
Beijing Sanbo Brain Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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
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
Secondary Outcomes
- Intracranial pressure(During the process of physiological study, up to 2 hours)
- 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)
- 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 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)