Tympanic Thermometers Accuracy

Last updated: January 24, 2025
Sponsor: Istituto Ortopedico Rizzoli
Overall Status: Completed

Phase

N/A

Condition

Fever

Treatment

latest generation tympanic thermometer

Clinical Study ID

NCT06103604
507/2023/Oss/IOR
  • Ages > 4
  • All Genders

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.

Eligibility Criteria

Inclusion

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 temperaturemeasurement

Exclusion

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.

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: latest generation tympanic thermometer
Phase:
Study Start date:
December 28, 2023
Estimated Completion Date:
October 31, 2024

Study 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

Connect with a study center

  • ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121
    Italy

    Site Not Available

  • Istituto Ortopedico Rizzoli

    Bologna, 40136
    Italy

    Site Not Available

  • Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico

    Firenze, 50139
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • APSS Trento

    Trento, 38123
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, 37126
    Italy

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.