Steadysense -Early Detection of Postoperative Infections Through Continuous Temperature Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Temperature curve (body temperature in °C)
研究概览
简要总结
The goal of this observational study is to review whether postoperative infections can be detected earlier by a continuous measurement of body temperature of patients compared to single daily measurements. Within 25 weeks 100 patients, which underwent visceral surgery less than 48h ago, will be included. A patch (Steadytemp ®) will be attached to participants, continuously measuring the body temperature. In addition infection parameters and medication of the participants will be documented.
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
- •participant is willing and able to give informed consent for participation in the study
- •age 18 years and above
- •visceral surgery procedure within the last two days
- •inpatient stay on the ICIÜ (Interdisciplinary surgical intensive care unit) or normal ward
排除标准
- •allergy to the ingredients of skin patches
- •major psychiatric diseases including history of drug or alcohol abuse
- •chronic inflammatory disease in the medical history
- •predicted inpatient stay is less than 5 days
- •operational wound is too close to the patch adhesive site
- •the skin at the intended adhesive site of the patch is not intact
- •BMI > 33
结局指标
主要结局
Temperature curve (body temperature in °C)
时间窗: min. 5 days and max. 21 days
temperature curve of the Steadytemp® Patch and single routine measurements (infrared)
wound infection or pneumonia
时间窗: min. 5 days and max. 21 days
Number of patients diagnosed with wound infection or pneumonia
次要结局
- Inflammation parameter in the blood: PCT (Procalcitonin)(min. 5 days and max. 21 days)
- Use of medication(min. 5 days and max. 21 days)
- Inflammation parameter in the blood: CRP (c-reactive protein)(min. 5 days and max. 21 days)
- Inflammation parameter in the blood: Leukocytes(min. 5 days and max. 21 days)