Clinical trial NCT06511986: M-I/E for Preventing VAP in Post-neurosurgical Patients
Official title: Impact of Mechanical Insufflation-Exsufflation on Ventilator-Associated Pneumonia in Post-Neurosurgical Patients: a Safety and Efficacy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Associated Pneumonia
Brain Injuries
Mechanical Insufflation-exsufflation
Lead sponsor: Beijing Sanbo Brain Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-neurosurgical adult patients receiving mechanical ventilation

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.


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

Primary outcomes:
measure: Mean blood pressure
timeFrame: during the process of physiological study, up to 2 hours
measure: Heart rate
timeFrame: During the process of physiological study, up to 2 hours
measure: Rate of ventilator associated pneumonia
timeFrame: Within 7 days after the onset of mechanical of ventilation
Secondary outcomes:
measure: Intracranial pressure
timeFrame: During the process of physiological study, up to 2 hours
measure: Length of stay in ICU
timeFrame: 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
measure: Length of hospital stay
timeFrame: 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
measure: Days of receiving mechanical ventilation
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Sanbo Brain Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Zhonghua Shi, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References: