Skip to main content
OpenTrials
Completed

NCT Number: NCT06511986

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventilator Associated Pneumonia Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Mechanical Insufflation-exsufflation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, 100090, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. Intracranial pressure

    Time frame: During the process of physiological study, up to 2 hours

    In study one, intracranial pressure will be recorded during the incremental pressure changes in the study one

  2. Length of stay in ICU

    Time frame: 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

    Days of ICU Stay

  3. Length of hospital stay

    Time frame: 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 hospital stay

  4. Days of receiving mechanical ventilation

    Time frame: 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

    The duration from the start of mechanical ventilation to the weaning off from ventilator

Sponsors and collaborators

Lead sponsor

Beijing Sanbo Brain Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.