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

Study Overview
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Brief Summary
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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.

Official Title
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Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

Conditions
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Haematological Malignancy

Intervention / Treatment
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* Device: Enteric capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temperature measurement<br>enteric capsule will be ingested every 24 hours during aplasia. Temperature measurement will be made continuously during aplasia. In parallel, auricular temperature will be measure every 4 hours during aplasia. | Device: Enteric capsule<br>* Enteric capsule to measure body temperature will be ingested every 24 hours during aplasia. the temperature measured with this technique will be compared with auricular temperature measurement (in current practice nurse measure temperature every 4 hours during aplasia).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule | the temperature in degrees Celsius measured by the 2 systems (left and right average for the auricular measure) and analysis of the concordance | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration | The time required to start anti-infective treatments according to the 2 measurement methods, in hours (effective start up thanks to the ear and theoretical measurement indicated by the enteric measurement) | 6 months | 
| Description of curves of temperature in the neutropenic patient measured continuously | Description of curves of temperature in the neutropenic patient measured continuously | 6 months | 
| Satisfaction of patient towards enteric capsule | auto-questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temperature measurement, capsule thermometers, Haematology