Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule
研究概览
简要总结
Connected medicine "2.0" is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc.
However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Major patient admitted to USIH for an aplasia episode of at least 7 days secondary to:
- •autograft conditioned by melphalan (MLP) or BEAM (BICNU, Etoposide, Aracytine, Melphalan) chemotherapy
- •Aracytin chemotherapy High dose (HD) or intermediate dose (DI)
- •Signed informed consent;
- •Affiliated or beneficiary of a social protection scheme.
排除标准
- •Diarrhea (> 3 stools /day) at the time of inclusion
- •Occlusive syndrome at the time of inclusion or patient at risk of developing occlusive syndrome
- •Persons with or likely to have intestinal disorders that may lead to obstruction of the digestive tract, including diverticulitis
- •People with digestive tract motility disorders
- •Persons equipped with a pacemaker or an electro-medical implant
- •Weight < 40 kg or BMI > 30
- •Patient for whom an MRI examination may be indicated during the trial period
- •Patient with proven swallowing disorders
- •Refusal to participate in the study
- •Induction of acute leukaemia or allograft
- •Person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
- •Pregnant, parturient or breastfeeding women;
- •Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problem, etc.)
- •Patient who has already been included in the TEMPET trial during treatment
结局指标
主要结局
Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule
时间窗: 6 months
the temperature in degrees Celsius measured by the 2 systems (left and right average for the auricular measure) and analysis of the concordance
次要结局
- Satisfaction of patient towards enteric capsule(6 months)
- Description of curves of temperature in the neutropenic patient measured continuously(6 months)
- Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration(6 months)