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

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Ventilator Associated Pneumonia; Mechanical Insufflation-exsufflation

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100090
      • Beijing Sanbo Brain Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Post-neurosurgical adult patients receiving mechanical ventilation

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean blood pressure	In study one, mean blood pressure will be recorded during the incremental pressure changes in the study one	during the process of physiological study, up to 2 hours
Heart rate	In study one, heart rate will be recorded during the incremental pressure changes in the study one	During the process of physiological study, up to 2 hours
Rate of ventilator associated pneumonia	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.	Within 7 days after the onset of mechanical of ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial pressure	In study one, intracranial pressure will be recorded during the incremental pressure changes in the study one	During the process of physiological study, up to 2 hours
Length of stay in ICU	Days of ICU Stay	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
Length of hospital stay	Days of hospital stay	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 receiving mechanical ventilation	The duration from the start of mechanical ventilation to the weaning off from ventilator	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

Collaborators and Investigators

• Sponsor: Beijing Sanbo Brain Hospital
• Investigators: Principal Investigator: Zhonghua Shi, PhD,MD, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): January 22, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cross Infection; Iatrogenic Disease; Pneumonia; Brain Injuries; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: VAP prevention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No