CompletedNot Applicable

Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

France30 participantsStarted 2019-06-21

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

What they're measuring

Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule

Timeframe: 6 months

Trial details

NCT IDNCT04174053

SponsorCentre Henri Becquerel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-07