FeverNCT02937129
Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department
An observational study of Fever, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
The primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Fever
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2015
- 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 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Febrile patients defined by a cut off of 37.5°C measured by axillary mercury thermometer were enrolled. Patients who meet the exclusion criteria were excluded.
Who may be able to join
- Above 37.5°C measured by axillary mercury thermometer
Who cannot join
- otitis external/media
- soft-tissue infection over the axillary fossa and forehead
- complete occlusion by earwax
- severe illness
- trauma
About this study
The primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic thermometer can replace an axillary mercury thermometer in the emergency department.
- Conditions
- Fever
- Keywords
- Infrared tympanic thermometer, Axillary thermometer, Mercury glass thermometer, Adult emergency department
- Medical subject headings
- Fever, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
The body temperatures of fever patients measured by the infrared tympanic thermometer
- Fever patients were measured by the infrared tympanic thermometer in the emergency department.
- Their tympanic temperatures were obtained from both sides of the body three times.
- Use statistical methods to evaluate the relevance and consistency between the tympanic temperatures and gold standard temperatures(measured by the glass mercury thermometer).
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
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.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangge Deng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937129
- Sponsor's protocol ID
- 20151A010093
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department
- ClinicalTrials.gov ID
- NCT02937129
- Acronym / sponsor ID
- 20151A010093
- Conditions
- Fever
- Keywords
- Infrared tympanic thermometer, Axillary thermometer, Mercury glass thermometer, Adult emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Oct 2016 (estimated)
- 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 primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic thermometer can replace an axillary mercury thermometer in the emergency department.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Febrile patients defined by a cut off of 37.5°C measured by axillary mercury thermometer were enrolled. Patients who meet the exclusion criteria were excluded.
Key inclusion criteria (1 listed)
- Above 37.5°C measured by axillary mercury thermometer
Key exclusion criteria (5 listed)
- otitis external/media
- soft-tissue infection over the axillary fossa and forehead
- complete occlusion by earwax
- severe illness
- trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The body temperatures of fever patients measured by the infrared tympanic thermometer
Time frame: up to 5 months
1. Fever patients were measured by the infrared tympanic thermometer in the emergency department. 2. Their tympanic temperatures were obtained from both sides of the body three times. 3. Use statistical methods to evaluate the relevance and consistency between the tympanic temperatures and gold standard temperatures(measured by the glass mercury thermometer).
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 18 Oct 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by The First Affiliated Hospital of Guangzhou Medical University.
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 1 inclusion and 5 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The body temperatures of fever patients measured by the infrared tympanic thermometer (time frame: up to 5 months). 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 18 Oct 2016.