Haematological Malignancy
Conditions
Keywords
Temperature measurement, capsule thermometers, Haematology
Brief 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.
Interventions
DEVICEEnteric capsule
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).
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration | 6 months | 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) |
| Description of curves of temperature in the neutropenic patient measured continuously | 6 months | Description of curves of temperature in the neutropenic patient measured continuously |
| Satisfaction of patient towards enteric capsule | 6 months | auto-questionnaire |
Countries
France
Outcome results
None listed