Comparison of the Incidence of Ventilator-Associated Pneumonia Between Integrated Mechanical Ventilator Cuff Pressure Monitoring and Manual Manometric Cuff Monitoring - A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of ventilator-associated pneumonia (VAP)
研究概览
简要总结
Ventilator-associated pneumonia (VAP) is a frequent complication in mechanically ventilated patients in intensive care unit (ICU). This prospective cohort study compares the incidence of VAP between patients whose endotracheal tube cuff pressure was controlled continuously using an integrated ventilator cuff-pressure control system versus intermittent manual manometric monitoring performed by staff.
详细描述
This single-center prospective cohort study enrolled consecutively screened ICU patients requiring invasive mechanical ventilation after severe head injury. Participants were allocated to exposure groups based on the ventilator to which they were connected at ICU admission, without investigator influence: (1) integrated continuous cuff pressure control via HAMILTON-C6 ventilator, or (2) intermittent manual cuff pressure checks using a manometer according to standard practice (every 8 hours and additionally during nursing/diagnostic-therapeutic procedures as needed), targeting cuff pressures of 20-30 cmH₂O.
Participants were followed for up to 7 days in ICU for development of VAP. VAP assessment used clinical, laboratory, radiological, and microbiological data summarized using the Clinical Pulmonary Infection Score (CPIS). Standard VAP prevention bundle measures were applied to both groups per unit protocol. All patients received prophylactic amoxicillin/clavulanic acid 1.2 g IV every 8 hours according to local protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •ICU admission after severe head injury
- •Endotracheal intubation and invasive mechanical ventilation
- •Expected mechanical ventilation >48-72 hours (recommended to add for PRS clarity)
- •Informed consent from family/legal representative
排除标准
- •Pneumonia/VAP diagnosed within the first 48 hours of ICU admission/ventilation
- •Removal or replacement of endotracheal tube during observation window
- •Tracheotomy performed within 7 days of admission
- •Missing required assessments/results (optional to include as operational exclusion)
研究组 & 干预措施
Cohort 1: Integrated cuff pressure control
Description Endotracheal tube cuff pressure continuously controlled and recorded by the ventilator's integrated cuff pressure control function (HAMILTON-C6)
干预措施: Continous measurement of cuff pressure in endotracheal tube (Procedure)
Cohort 2: Manual manometric cuff pressure monitoring
Description Endotracheal tube cuff pressure monitored by staff using a manometer, checked at least every 8 hours and additionally during routine nursing procedures and diagnostic/therapeutic interventions, targeting 20-30 cmH₂O.
干预措施: Intermittent manual cuff pressure monitoring with manometer. (Procedure)
结局指标
主要结局
Incidence of ventilator-associated pneumonia (VAP)
时间窗: From Day 3 to Day 7 (assessed on days 3, and 7; VAP defined as onset >48-72 hours after initiation of invasive ventilation)
VAP occurrence defined by CPIS threshold ≥7 (scale range 0-12), incorporating clinical parameters (temperature, tracheal secretions), laboratory leukocyte count, oxygenation (PaO₂/FiO₂), chest radiography findings, and microbiology
次要结局
- Median/average cuff pressure during ICU stay (cmH₂O)(from Day 3 to Day 7)
- Number of cuff-pressure events outside target range (<20 or >30 cmH₂O)(from Day 3 to Day 7)
- Duration of mechanical ventilation among VAP-positive participants (hours)(from Day 0 to discharge from the ICU)
- ICU and/or hospital length of stay (days)(until discharge from ICU/hospital)