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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-04

Study Completion Date

2025-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventilator Associated Pneumonia Brain Injuries Mechanical Insufflation-exsufflation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No