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Tympanic Thermometers Accuracy

NCT06103604 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2025-01-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Eligibility

Min Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06103604 on ClinicalTrials.gov