Nurse-Led Bispectral Index (BIS)-Guided Sedation Protocol and Its Impact on Clinical Outcomes in Mechanically Ventilated Pediatric Intensive Care Patients: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Time Spent Outside BIS Target Range
研究概览
简要总结
Pediatric intensive care sedation is traditionally based on subjective clinical scales. Bispectral Index (BIS) monitoring provides an objective EEG-based assessment of sedation depth. This prospective, two-center randomized controlled trial evaluates whether a nurse-led BIS-guided sedation protocol can reduce excessive or inadequate sedation, sedative medication exposure, withdrawal symptoms, and PICU length of stay in mechanically ventilated children.
详细描述
This prospective, randomized (1:1) controlled trial was conducted in two tertiary PICUs in Turkey, including mechanically ventilated children aged 1 month to 18 years requiring continuous sedation. Patients were randomly assigned to:
Intervention Group: Nurse-led sedation titration using BIS values (target: light sedation 60-80, deep sedation 45-60) combined with SBS scores under physician supervision. Nurses received structured theoretical and practical training before trial initiation.
Control Group: Standard sedation protocol based solely on clinical sedation assessment without BIS-guided titration (BIS monitoring available but not used for titration).
Primary Outcome:
Percentage and duration of time spent outside the target BIS range
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 month and 18 years
- •Receiving invasive mechanical ventilation
- •Expected to require sedation for ≥24 hours
- •Hemodynamically stable at enrollment
- •BIS monitoring electrode placement feasible
排除标准
- •Use of neuromuscular blocking agents at enrollment
- •Mechanical ventilation expected to last <24 hours
- •Severe hemodynamic instability requiring escalating vasoactive support
- •Known neurological disorders that prevent reliable BIS interpretation (e.g., severe encephalopathy, epileptic burst suppression)
- •Facial burns or skin conditions preventing BIS electrode placement
- •Decision for palliative/comfort care only
结局指标
主要结局
Time Spent Outside BIS Target Range
时间窗: First 72 hours of mechanical ventilation
otal duration (in hours) during which BIS values remain outside the predefined sedation targets (light sedation: 60-80; deep sedation: 45-60). This measure reflects adequacy of sedation and protocol effectiveness.
Cumulative Midazolam Dose
时间窗: Up to 28 days or until extubation
otal midazolam dose administered (mg/kg) during mechanical ventilation.
Cumulative Ketamine Dose
时间窗: Up to 28 days or until extubation
Total ketamine dose administered (mcg/kg) during mechanical ventilation.
Cumulative Dexmedetomidine Dose
时间窗: Up to 28 days or until extubation
Total dexmedetomidine dose administered (mcg/kg) during mechanical ventilation.
次要结局
- Withdrawal Severity (WAT-1 Score)(First 7 days of PICU stay)
- PICU Length of Stay(Up to 28 days)
研究者
Hasan ağın
Prof.Dr
Dr. Behcet Uz Children's Hospital