Effect of Active Versus Passive Humidification on Airway Complications and Clinical Outcomes in Trauma ICU Patients With Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Incidence of Clinically Significant Airway Obstruction
研究概览
简要总结
This study compares the effects of two primary airway humidification methods-active heated humidifiers (HHs) and passive heat-and-moisture exchangers (HMEs)-on trauma intensive care unit (ICU) patients requiring prolonged mechanical ventilation. Adequate humidification is essential during mechanical ventilation because artificial airways bypass the body's natural ability to warm and moisten inhaled air. While existing guidelines show no overall superiority of one method over the other in general ICU populations, trauma patients present unique challenges, such as thick or bloody secretions, which may lead to airway obstructions and affect the performance of these devices.
The main purpose of this randomized controlled trial is to evaluate how active versus passive humidification impacts airway complications (such as secretion viscosity and tube obstruction) and clinical outcomes (including ventilator-associated pneumonia, duration of mechanical ventilation, length of ICU stay, and mortality rates). A total of 162 adult trauma patients at Assiut University Hospital will be randomly assigned to either the HH group or the HME group to determine if there are significant clinical differences between the two methods in this specific patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age 18-65 years.
- •Trauma ICU patients receiving invasive mechanical ventilation.
- •Anticipated to require prolonged mechanical ventilation, defined as ≥7 days of invasive ventilatory support
排除标准
- •Immunosuppression such as HIV, cancer or AIDS.
- •Blood leukocyte count <1,000 cells/mm
- •Withdrawal of life-sustaining treatment within 5 days.
- •Use of HME in conjunction with an HH.
- •Contraindications of HME including body temperature < 32°C, copious, thick, or bloody secretions, significant air leak (exhaled VT >70% of VT inspired) or broncopleural fistula
结局指标
主要结局
Incidence of Clinically Significant Airway Obstruction
时间窗: From study enrollment up to 14 days of mechanical ventilation.
Defined as an unexplained increase in airway resistance (\>15 cmH₂O/L/s) and/or peak airway pressure (\>35 cmH₂O or a sudden increase of 5-10 cmH₂O above baseline) accompanied by evidence of secretion retention, thick secretions with increased suction burden, mucus plugging, partial or complete tube occlusion, difficulty in suction catheter passage, or the need for airway intervention such as bronchoscopy or tube exchange.
次要结局
- Incidence of Ventilator-Associated Pneumonia (VAP)(Daily from study enrollment until ICU discharge, up to 30 days.)
- Duration of Mechanical Ventilation(Daily from study enrollment until successful weaning, up to 30 days.)
- ICU Length of Stay(Through ICU discharge, up to 30 days.)
- Total Estimated Hospitalization Cost(At the time of ICU discharge, up to 30 days.)
- Frequency of Endotracheal Tube Exchange(Daily from study enrollment until ICU discharge, up to 30 days.)
- Arterial Oxygenation Status (PaO2/FiO2 Ratio)(Daily from initiation until liberation from mechanical ventilation.)
- ICU Mortality Rate(Through ICU discharge, up to 30 days.)
研究者
Mostafa Muhammad Ahmad Ali
Assistant lecturer of Critical Care and Emergency Nursing
Assiut University