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Completed

NCT Number: NCT06103604

Tympanic Thermometers Accuracy

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.

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Key information

Age range

4 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Paediatric patients over the age of 4 months
  • adults admitted to intensive care and resuscitation
  • undergoing surgery who by current practice undergo invasive core temperature measurement

Exclusion criteria

  • Patients with bilateral auricular inflammatory problems,
  • patients who will not use the gold standard for clinical reasons,
  • patients or legal guardians who do not consent to participate in the study.

Treatment and study plan

latest generation tympanic thermometer

Diagnostic Test

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.

Primary outcomes

  1. Measure of Agreement

    Time frame: The temperature measurement will be taken on each patient enrolled up to 2 weeks

    Measure of Agreement between the thermometer and the gold standard to be assessed by the Bland and Altman method.

Secondary outcomes

  1. accuracy

    Time frame: The temperature measurement will be taken on each patient enrolled up to 2 weeks

    sensitivity, specificity, predictive values, likelihood ratios

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 27, 2023
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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