持续体温监测
检查用于连续监测成人体温的远程医疗系统 - 一项试点研究
This is a nonrandomized, diagnostic, single-center, pilot study, with one group of participants. The aim is to examine the effectiveness and safety of telemedicine system for continuous measurement of body temperature in adults. Up to 40 subjects will participate in this phase of the clinical trial. No stratification, nor randomization of subjects will be performed. Respondents who meet the inclusion criteria will be monitored for up to 72 hours plus 72 hours after removing the device. Namely, the device will be placed on their body and will be there until upt to 72 hours, and then it will be removed. The respondent will be monitored by the team for an additional 72 hours by the person in charge of the examination, for possible side effects.
Sensor will be placed in the axilar joint or a little below on the side. The device will be connected to a mobile phone. Member of the research team (principal researcher/co-researcher/ nurse in charge of examination) measures the temperature of the skin in the opposite armpit manually, ie with a gallium thermometer and records every 30-60 minutes. When body temperature starts to rise, a member of the research team measures the body temperature every 15-30 minutes. After reaching a stable temperature, the temperature is measured every 30-60 minutes. If the subject is given drugs to lower body temperature, the temperature is measured again every 15-30 minutes until the temperature stabilizes to a normal subfebrile state.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Other/Not Applicable
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Belgrade、Other/Not Applicable、塞尔维亚、11000
- University Clinical Center of Serbia, Clinic for Infectious and Tropical Diseases
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Up to 40 eligible participants with disease and/or condition that results in body temperature variation will be included in the study.
描述
Inclusion Criteria:
- A person of male or female sex
- Age 18 and over
- Ability to measure the patient's body temperature frequently
- People who are hospitalized due to any type of infection or any other diseases that result in variations in body temperature (rise, fall)
- Completed all potential diagnostics of the hospitalized patient (no interrupting the measurement of the telemedicine device)
Exclusion Criteria:
- Allergic to contact with plastic or silver
- Anatomical anomalies that prevent the placement of the system
- High-risk health conditions, intensive care and the like
- A pacemaker or other device on the skin or implanted in the body that emits light electromagnetic radiation
学习计划
研究是如何设计的?
设计细节
- 观测模型:CASE_CONTROL
- 时间观点:PROSPECTIVE
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation Coefficient
大体时间:Up to 72 hours
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The correlation between the Baby FM continuous temperature monitoring device and a reference standard gallium thermometer is expected to be high. The primary outcome was the correlation coefficient using all paired temperature measurements from the overall study population. Participant-level correlation coefficients were also calculated for individual participants. Higher correlation coefficients indicate a stronger linear association between measurements from the two devices. |
Up to 72 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of Device and Procedure Related Adverse Events
大体时间:Up to six days
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The number and percentage of adverse events related to the investigational product will be evaluated and summarized. |
Up to six days
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- BABYFM-010
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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