Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric ICU Patients:Further Refinement and Validation of eProtocol-insulin
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- The primary outcome variable during Phase I will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions: more than 90 % of all instructions accepted by the bedside clinician).
研究概览
简要总结
The Purpose of this study is to:
- Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.
- Monitor how often low blood sugar levels occur during use of the bedside tool.
- Determine how the computerized tool effects the workload of the ICU nurses.
详细描述
This first phase will be a prospective cohort study. We will validate the bedside tool in at least 4 adult and at least 4 pediatric ICUs and if necessary we will modify the bedside tool. The computerized bedside tool will be considered refined if >90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl is less than 0.5% of glucose measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for glucose control in their ICUs would include patients who require mechanical ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g. dopamine >3 mg/kg/min, dobutamine, epinephrine, or vasopressin).
- •Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose control in participating adult ICUs include critically ill patients with an anticipated ICU length of stay of 3 or more days.
排除标准
- •Pregnancy (negative pregnancy test required for females of child-bearing age)
- •Age less than one month
- •Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis
- •Acute or chronic liver disease with any documented episode of blood or plasma glucose <60 mg/dl within the 24 hours prior to study entry
- •Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in ketoacidosis will be eligible if attending physicians intend to use intravenous insulin as part of ordinary care)
- •Severe chronic liver disease (Child-Pugh score >10)
研究组 & 干预措施
eProtocol
干预措施: glucose control with computer generated recommendations (Procedure)
结局指标
主要结局
The primary outcome variable during Phase I will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions: more than 90 % of all instructions accepted by the bedside clinician).
时间窗: 3 years
次要结局
- Proportion of glucose determinations within the range of 70-110 mg/dl (3.9-6.1 mMol/l)(3 years)
- Nursing perception of workload in comparison to ordinary care(3 years)