Clinical trial NCT06103604: Tympanic Thermometers Accuracy
Official title: The Diagnostic Accuracy and Precision of the Latest Generation Tympanic Thermometers in the Adult and Paediatric Population: Multicentre Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Keywords: Thermometers
Sensitivity and Specificity
Hypothermia
Hyperthermia
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 1100
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to acute hospitals

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of Agreement
timeFrame: The temperature measurement will be taken on each patient enrolled up to 2 weeks
Secondary outcomes:
measure: accuracy
timeFrame: The temperature measurement will be taken on each patient enrolled up to 2 weeks
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Bologna
country: Italy
facility: Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Trento
country: Italy
facility: APSS Trento
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
Study officials:
References: