Evaluating the Clinical Utility of Modified Ventilator-Associated Event Criteria in Predicting ICU Mortality and Ventilator Duration: Can Less Restrictive Definitions Improve Prediction?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ventilator-Free Days at Day 28 (VFD-28)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years) undergoing mechanical ventilation for ≥ 48 hours.
- •Patients admitted to ICU for
- •surgical conditions.
排除标准
- •Age below 18 years.
- •extracorporeal life support (ECLS).
- •Incomplete or inconsistent daily monitoring data.
- •Patients with confirmed or suspected respiratory viral infections (e.g., influenza, COVID-19).
- •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.
- •chronic ventilator dependency prior to ICU admission.
- •incomplete medical documentation impacting data collection or outcome analysis.
- •severe immunosuppression, such as recent bone marrow or organ transplant recipients, and those on high-dose corticosteroids.
结局指标
主要结局
Ventilator-Free Days at Day 28 (VFD-28)
时间窗: at Day 28
Ventilator-Free Days at Day 28 (VFD-28): The number of days a patient is alive and free from mechanical ventilation within the first 28 days after initiation of mechanical ventilation. Patients who die before day 28 will be assigned a value of zero VFDs.
* Prolonged Mechanical Ventilation
时间窗: for 7 days
\* Prolonged Mechanical Ventilation (≥7 Days): The proportion of patients requiring mechanical ventilation for 7 days or more.
次要结局
- Incidence of VAE, VAE24, and Light-VAE: The proportion of patients meeting each definition of VAE.(within 30 days of IC)
- Duration of Mechanical Ventilation:(within 30 days of ICU admission.)
- Length of ICU Stay:(within 30 days of ICU admission.)
- Length of Hospital Stay:(within 30 days of ICU admission.)
- ICU Mortality Rate:(within 30 days of ICU admission.)
- Day -30 Mortality Rate:(within 30 days of ICU admission.)
研究者
Amal Hosam Eldin Mohamed Fahmi
Assistant lecturer
Benha University