FeverNCT06103604
Tympanic Thermometers Accuracy
An observational study of Fever, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 4 months and older
- Conditions the study is for
- Fever
- What is being tested?
- latest generation tympanic thermometer
- How many people
- 1,100 participants
- Where
- 7 sitesItaly
- Study dates
- 28 Dec 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients admitted to acute hospitals
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Istituto Ortopedico Rizzoli
Bologna, 40136
Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Azienda Ospedaliera Universitaria Meyer Istituto di Ricovero e Cura a Carattere Scientifico
Florence, 50139
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
APSS Trento
Trento, 38123
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126
About this study
Official title: 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.
Read the 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
- Conditions
- Fever
- Being tested
- latest generation tympanic thermometer
- Keywords
- Thermometers, Sensitivity and Specificity, Hypothermia, Hyperthermia
- Medical subject headings
- Fever, Hypersensitivity, Hypothermia, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
latest generation tympanic thermometerDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| in-patients requiring temperature monitoring | The patient at any age whose core temperature is monitored during hospitalisation Receives: Diagnostic Test: latest generation tympanic thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Agreement
Measure of Agreement between the thermometer and the gold standard to be assessed by the Bland and Altman method.
Measured: The temperature measurement will be taken on each patient enrolled up to 2 weeks
Secondary outcomes (1)
accuracy
sensitivity, specificity, predictive values, likelihood ratios
Measured: The temperature measurement will be taken on each patient enrolled up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start28 Dec 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103604
- Sponsor's protocol ID
- 507/2023/Oss/IOR
- Status last verified
- Jan 2025
- First submitted
- 18 Oct 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Accuracy and Precision of the Latest Generation Tympanic Thermometers in the Adult and Paediatric Population: Multicentre Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06103604
- Acronym / sponsor ID
- 507/2023/Oss/IOR
- Conditions
- Fever
- Keywords
- Thermometers, Sensitivity and Specificity, Hypothermia, Hyperthermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| in-patients requiring temperature monitoring | – | Diagnostic Test: latest generation tympanic thermometerThe patient at any age whose core temperature is monitored during hospitalisation |
Who may qualify
- Ages
- 4 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted to acute hospitals
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| latest generation tympanic thermometerThe 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. | Diagnostic test | in-patients requiring temperature monitoring |
Primary outcome
Measure of Agreement
Time frame: The temperature measurement will be taken on each patient enrolled up to 2 weeks
Measure of Agreement between the thermometer and the gold standard to be assessed by the Bland and Altman method.
1 secondary outcome
accuracy
Time frame: The temperature measurement will be taken on each patient enrolled up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by Istituto Ortopedico Rizzoli at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Agreement (time frame: The temperature measurement will be taken on each patient enrolled up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.