Tympanic Thermometers Accuracy

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

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.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Diagnostic test: latest generation tympanic thermometer

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

• Study Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli
  • Bologna, Italy, 40138
    • Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
  • Firenze, Italy, 50139
    • Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Trento, Italy, 38123
    • APSS Trento
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata di Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to acute hospitals

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

in-patients requiring temperature monitoring; The patient at any age whose core temperature is monitored during hospitalisation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy	sensitivity, specificity, predictive values, likelihood ratios	The temperature measurement will be taken on each patient enrolled up to 2 weeks

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Hypothermia; Thermometers; Hyperthermia; Sensitivity and Specificity
• Other Study ID Numbers: 507/2023/Oss/IOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No