Pilot Observation of Continuous Glucose Monitoring in Critically Ill Patients Under Consideration of Accuracy, Feasibility and Acceptance by Ward Staff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Accuracy of continuous glucose monitoring compared to blood gas analyses
研究概览
简要总结
Critically ill patients are on high risk for increased serum glucose levels, leading to more comorbidity and higher mortality risk. In patients with severe sepsis and septic shock hyperglycemia is a typical finding. However the need of insulin therapy is associated with an increased risk of hypoglycemia. Newly developed technologies for continuous glucose monitoring in critically ill patients may improve glycemic control and reduce glucose variability. The investigators will perform continuous glucose monitoring in critically ill patients on ICU. Measurements will be done for a period of 72h per patient. The investigators aim is to evaluate accuracy feasibility and acceptance of these methods. To analyze accuracy sensor glucose levels will be validated due to arterial blood gas measurements with the blood gas analyzer. The investigators will investigate the influence of several factors like oedema, perspiration, BMI, body temperature, pH-value application of vasoconstrictors on accuracy and feasibility of the particular system. Furthermore Nursing staff will be given a questionnaire to identify acceptance.
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
- Diagnostic
- 盲法
- None
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
- •critically ill patients with expected ICU stay for more than 72 hours
- •informed consent by the patients or legal proxy
排除标准
- •age < 18
- •no informed consent by the patients or legal proxy
- •pregnancy
- •infaust prognosis
研究组 & 干预措施
SOFA <7
Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score < 7 at first day of measurement.
Intervention: Measuring continuous glucose monitoring.
干预措施: Continuous glucose monitoring (Device)
SOFA >7
Critically ill patients with a Sequential Organ Failure Assessment (SOFA) score > 7 at first day of measurement.
Intervention: Measuring continuous glucose monitoring.
干预措施: Continuous glucose monitoring (Device)
结局指标
主要结局
Accuracy of continuous glucose monitoring compared to blood gas analyses
时间窗: 72 hours
Difference between glucose values of continuous glucose monitoring and blood gas analyses
次要结局
- Feasibility of continuous glucose monitoring(72 hours)
- Acceptance of continuous glucose monitoring by physicians and nursing staff(72 hours)
研究者
Steffen Weber-Carstens
PD Dr. med. Steffen Weber-Carstens
Charite University, Berlin, Germany
