Tympanic Thermometers Accuracy

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103604
• Other study ID #: 507/2023/Oss/IOR
• Status: Recruiting
• Start date: December 28, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: cristiana Forni, RN
• Phone: 3474809086
• Email: cristiana.forni[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: December 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Fever

Intervention

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.

Locations

Country	Name	City	State
Italy	ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna	Bologna
Italy	Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico	Firenze
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	APSS Trento	Trento
Italy	Azienda Ospedaliera Universitaria Integrata di Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Agreement	Measure of Agreement between the thermometer and the gold standard to be assessed by the Bland and Altman method.	The temperature measurement will be taken on each patient enrolled up to 2 weeks
Secondary	accuracy	sensitivity, specificity, predictive values, likelihood ratios	The temperature measurement will be taken on each patient enrolled up to 2 weeks