跳至主要内容
临床试验/NCT06447337
NCT06447337招募中不适用

Examination of a Telemedicine System for Continuous Monitoring of Body Temperature in Adults - a Pilot Study

Baby FM Doo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Correlation between device for continous body temperature monitoring and standard thermometer

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Correlation between device for continous body temperature monitoring and standard thermometer

时间窗: up to 72 hours

The correlation between temperature measurements with the standard hospital thermometer (with galium) is expected to be high

次要结局

  • Frequency of device and procedure related adverse events(up to six days)

研究者

发起方
Baby FM Doo
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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