NCT06103604

Tympanic Thermometers Accuracy

The Diagnostic Accuracy and Precision of the Latest Generation Tympanic Thermometers in the Adult and Paediatric Population: Multicentre Cross-sectional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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

Conditions

• Fever

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	latest generation tympanic thermometer	The patient whose core temperature is monitored during hospitalisation has his temperature at tympanic level taken once during the stay. 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. Only the first tympanic measurement will then be used to assess accuracy against the gold standard.

Timeline

• Start date: 2023-12-28
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-10-27
• Last updated: 2025-01-27

Locations

7 sites across 1 country: Italy