NCT07212881

Evaluating the Clinical Utility of Modified Ventilator-Associated Event Criteria in Predicting ICU Mortality and Ventilator Duration: Can Less Restrictive Definitions Improve Prediction?

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study design: A prospective observational study * Study setting: The study will be carried out in the department of critical care medicine, Benha university hospitals. * Study time: The study time is set to a period of one year from March 2025 to March 2026.

Detailed description

Technical design: * Study design: A prospective observational study * Study setting: The study will be carried out in the department of critical care medicine, Benha university hospitals. * Study time: The study time is set to a period of one year from March 2025 to March 2026. Study population: The study will be conducted on 200 mechanically ventilated patients. ● Inclusion Criteria Adult patients (age ≥ 18 years) undergoing mechanical ventilation for ≥ 48 hours. Patients admitted to ICU for medical, trauma, or surgical conditions. ● Exclusion Criteria Age below 18 years. Patients on extracorporeal life support (ECLS). Incomplete or inconsistent daily monitoring data. Patients with confirmed or suspected respiratory viral infections (e.g., influenza, COVID-19). Patients undergoing palliative care or with a do-not-intubate (DNI) status. Pregnant patients due to altered physiological responses. Patients ventilated for less than 48 hours. Patients with chronic ventilator dependency prior to ICU admission. Cases with incomplete medical documentation impacting data collection or outcome analysis. Patients with severe immunosuppression, such as recent bone marrow or organ transplant recipients, and those on high-dose corticosteroids. Monitoring Parameters Daily assessment of the following: Fraction of inspired oxygen (FiO2). Positive end-expiratory pressure (PEEP). Record minimum daily values for accurate trend analysis. VAE Definitions Based on CDC Guidelines (6) Standard VAE: Sustained increase for ≥2 days in FiO2 ≥ 0.2, or PEEP ≥ 3 cm H2O ● Modified Definitions: VAE24: Increase for 1 day with FiO2 ≥ 0.2 or PEEP ≥ 3 cm H2O. Light-VAE: sustained increase of the daily minimum value in FiO2 ≥ 2 or PEEP ≥ 2 cmH2O or FiO2 ≥ 0.15 plus PEEP ≥ 1 cmH2O for two or more days. Patients management on mechanical ventilator: VAP Bundle: Key elements of the bundle include elevating the head of the bed to 30-45 degrees to reduce aspiration risk, performing daily assessments for readiness to extubate, and conducting spontaneous awakening and breathing trials to minimize ventilation duration. Proper oral hygiene with chlorhexidine helps maintain oral health and reduce bacterial colonization. Sedation protocols are optimized by using minimal sedation and assessing sedation levels regularly to avoid prolonged ventilation. Additionally, deep vein thrombosis (DVT) prophylaxis and peptic ulcer disease (PUD) prevention are essential components to mitigate secondary complications. (7) Data Measurements: 1. Demographic and Baseline Data Age / Gender / BMI/ APACHE II score/ chronic diseases/ type of patient (medical- surgical - trauma) / reasons for mechanical ventilation 2. Mechanical Ventilation Parameters Initial FiO2 and PEEP levels - Duration of mechanical ventilation (in days) 3. VAE Monitoring Data Classification of VAE (VAE, VAE24, Light-VAE) 4. Outcome Data ICU mortality - ICU length of stay - Hospital stay- 30 days mortality

Conditions

• Ventilator-Associated Events

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

1 site across 1 country: Egypt