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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| La Région Basse-Normandie | OTHER |
| Université de Caen Normandie | OTHER |
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E-Celsius device used for measuring the gastrointestinal temperature is composed of an ingestible capsule measuring the temperature as well as a transportable module receiving data from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The main risks related to such devices are related to biocompatibility (in materials used for the capsule shell, or level of contamination of the gastrointestinal environment due to a defect in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials; see section 10.2).
It will compare conventional methods of estimating the central temperature continuously with gastrointestinal data obtained from the e-Celsius device. The main objective of the research is to validate the extent of gastrointestinal temperature obtained from the device under test consists of an ingestible electronic capsule and a data reception monitor.
Secondary objectives will be pursued:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| temperature measurements with 4 devices | Experimental | temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Celsius thermometer | Device | comparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| body temperature | comparisons between device e-Celsius, esophageal probe and a rectal probe | from baseline to 36 hours every minute |
| Measure | Description | Time Frame |
|---|---|---|
| body temperature during ingestion of cold drinks | Assess the effects of ingestion of cold drinks on temperature readings taken via e-device Celsius, esophageal probe and a rectal probe | baseline |
| temperature of the digestive tract |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | 14033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36796916 | Result | Koumar OC, Beaufils R, Chesneau C, Normand H, Bessot N. Validation of e-Celsius gastrointestinal telemetry system as measure of core temperature. J Therm Biol. 2023 Feb;112:103471. doi: 10.1016/j.jtherbio.2023.103471. Epub 2023 Jan 9. |
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| Rectal thermometer | Device |
|
| Esophageal thermometer | Device |
|
| Vital sense capsule thermometer | Device |
|
Explore the thermal homogeneity of the digestive tract
| from baseline to 36 hours every minute |
| number of lost data | The capacity of the for each measurements method to store temperature data in the internal memory and send it to the receiver when the it is in the receiving area. | from baseline to 36 hours every minute |
| reliability of measurements | reliability of the measurement system while comparing it to the standards used by health staff today | from baseline to 36 hours every minute |
| ID | Term |
|---|---|
| D013821 | Thermometers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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