Temple Touch Pro (TTP) Non-Invasive Core Temperature Monitoring as a Measure for Early Detection of Fever Related Infections, Including Sepsis.
试验速览
- 阶段
- 不适用
- 发起方
- Medisim Ltd
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Continuously measure body temperature using TTP
研究概览
简要总结
The study has 2 phases:
- The Retrospective Phase (50 patients were diagnosed to have sepsis according to our definition and criteria and 30 patients as a controlled cases )
- The Prospective Phase (600 patients who will be admitted and monitored in ICU in order to get at least 30 sepsis cases, according to our definition and criteria).
Measurements will be made from the forehead using the TTP's biocompatible sensor Unit that will be attached to the skin. The SU will transfer data to the MCU.
详细描述
TTP™ system, which is composed of 2 parts:
- SU - a disposable Sensor Unit patch
- MCU - e reusable Monitor Connecting Unit
The communication between the two units can be wired or wireless. The system to be used in this study is wired and the two units were connected via a Sensor Unit Cable (SCU).
The SU is attached to the temple area by a biocompatible disposable adhesive. It measures skin temperature across the temporal artery using several sensors, translates it to electrical signals and transmits those signals to the MCU. The MCU translates the electrical signals to core temperature using a special mathematical algorithm which overcomes the effect of the ambient temperature as well as the thermal properties of a specific patient. The core temperature as well as any concurrent error in the measurement process is displayed on the screen of the MCU or transmitted to the hospital VSM. The MCU has a wired connection to the hospital's VSM using Standard YSI400.
Study Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •The Retrospective Phase
- •Both genders (Male or Female).
- •Aged 18 years and/or above.
- •Patients were Admitted to our ICU for more than 3 days, and shall be at least 72 hours prior to sepsis or infection detection in the ICU The Prospective Phase
- •Both genders (Male or Female).
- •Aged 18 years and/or above. Patients expected to be admitted to our ICU for more than 3 days
排除标准
- •The patients will be excluded from the trial if one of the following occurs:
- •The Retrospective Phase
- •No exclusion criteria The Prospective Phase
- •The medical staff decides that the patien t should not participate.
- •Unavailable measurement site in case of head injury in the head area.
- •Unavailable measurement reading during admission to ICU
结局指标
主要结局
Continuously measure body temperature using TTP
时间窗: Estimated time frame of the trial is 18 months.
During the trial, temperature measurements will be conducted using the TTP™ and currently used thermometers which are in routine use, later to be regarded as reference methods To examine the effectiveness of the TTP™ as a measure for detection of temperature changes pattern and to correlate such changes with fever related to infections such as sepsis.
次要结局
未报告次要终点