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

NCT06511986 | Completed

• 1 other identifier: VAP prevention
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia; Brain Injuries; Mechanical Insufflation-exsufflation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Intracranial pressure

  During the process of physiological study, up to 2 hours

• Length of stay in ICU

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-neurosurgical adult patients receiving mechanical ventilation

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Beijing Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing Municipality, 100090, China

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhonghua Shi, PhD,MD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of dept. ICU

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 22, 2024
• Study Start: March 4, 2024
• Primary Completion: January 22, 2025
• Study Completion: March 15, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)