Tympanic Thermometers Accuracy

NCT06103604 | Completed

• 1 other identifier: 507/2023/Oss/IOR
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 7

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.

Conditions

Fever

Keywords

Thermometers; Sensitivity and Specificity; Hypothermia; Hyperthermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• accuracy

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

Study Arms (1)

in-patients requiring temperature monitoring

The patient at any age whose core temperature is monitored during hospitalisation

Diagnostic Test: latest generation tympanic thermometer

Interventions

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.

in-patients requiring temperature monitoring

Eligibility Criteria

• Age: 4 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted to acute hospitals

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (7)

ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

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

Florence, 50139, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

APSS Trento

Trento, 38123, Italy

Location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37126, Italy

Location

MeSH Terms

Conditions

Fever; Hypersensitivity; Hypothermia; Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Heat Stress Disorders; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 27, 2023
• Study Start: December 28, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

IT (7)