Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT06103604
Brief Summary:
The aim of the present study is to evaluate the measurement precision and accuracy of the third-generation tympanic thermometer in relation to the measurement modalities considered gold standard. The evaluation of the instrument will be conducted in relation to the different calibration times of the tympanic thermometer, the level of re-training of healthcare personnel in the use of the instrument and the adult and paediatric population subjected to the measurement. Finally, the diagnostic capacity of the instrument in correctly identifying states of hypothermia and febrile elevations will be assessed.
Detailed Description:
The temperature measurement will be taken on each patient enrolled at a single time by the caregiver for that patient. As the measurements do not depend on which side they are taken, the most convenient side will be chosen. Each patient will only be included once
The research nurse will record the core temperature from the monitor on the CRF and, within the next 5 minutes, take the peripheral temperature with the tympanic thermometer three times in a row, recording all three values on the CRF. Subsequently a second operator will always take the temperature 3 times within 5 minutes of the gold standard measurement. The gold standard (reference tests), as indicated in the literature, can be either the thermometer inserted in the probe placed in the pulmonary artery, or the thermometer inserted in the bladder catheter or oesophageal probe, or directly a rectal thermometer.
Only the first tympanic measurement will then be used to assess accuracy against the gold standard. The other measurements above will only be evaluated for inter and intra reliability. The unit under study is therefore the individual patient at a precise point in time
Study:
NCT06103604
Study Brief:
Protocol Section:
NCT06103604