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

Impact of Mechanical Insufflation-Exsufflation on Ventilator-Associated Pneumonia in Post-Neurosurgical Patients: a Safety and Efficacy Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06511986
Enrollment
210
Registered
2024-07-22
Start date
2024-03-04
Completion date
2025-03-15
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Mechanical Insufflation-exsufflation, Ventilator Associated Pneumonia

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.

Interventions

None listed

Sponsors

Beijing Sanbo Brain Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean blood pressureduring the process of physiological study, up to 2 hoursIn study one, mean blood pressure will be recorded during the incremental pressure changes in the study one
Heart rateDuring the process of physiological study, up to 2 hoursIn study one, heart rate will be recorded during the incremental pressure changes in the study one
Rate of ventilator associated pneumoniaWithin 7 days after the onset of mechanical of ventilationIn 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.

Secondary

MeasureTime frameDescription
Intracranial pressureDuring the process of physiological study, up to 2 hoursIn study one, intracranial pressure will be recorded during the incremental pressure changes in the study one
Days of receiving mechanical ventilationPatients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 yearThe duration from the start of mechanical ventilation to the weaning off from ventilator
Length of stay in ICUPatients 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 yearDays of ICU Stay
Length of hospital stayPatients will be followed up until 28 days after surgery, discharged from hospital or dead, which ever came firstthrough study completion, an average of 1 yearDays of hospital stay

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026