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

B

Beijing Sanbo Brain Hospital

Status

Completed

Conditions

Brain Injuries
Ventilator Associated Pneumonia
Mechanical Insufflation-exsufflation

Study type

Observational

Funder types

Other

Identifiers

NCT06511986
VAP prevention

Details and patient eligibility

About

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.

Enrollment

210 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Zhonghua Shi, PhD,MD; Xiang Qi 3643112610@163.com, MD

Data sourced from clinicaltrials.gov

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