Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000296932
Ethics application status
Not yet submitted
Date submitted
17/03/2011
Date registered
21/03/2011
Date last updated
21/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of methods for assessing temperature measurement in emergency department patients requiring temperature measurement to determine accuracy of tympanic, infrared skin thermometry with the gold standard of rectal thermometry
Scientific title
Comparison of methods for assessing temperature measurement in emergency department patients requiring temperature measurement to determine accuracy of tympanic, infrared skin thermometry with the gold standard of rectal thermometry
Secondary ID [1] 259809 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temperature measurement in emergency department patients 261390 0
Condition category
Condition code
Infection 265545 265545 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Two groups of emergency patients who require temperature measurement as a part of their clinical assessment will have a single set of temperature measurement taken upon arrival in the emergency department. The first group will be adults, 18 years and over, who will under go tympanic, temporal artery and oral temperature measurement. The second group will be infants 3 months and younger who will have temporal artery, tympanic and rectal temperature measurement performed. Patients will be recruited over a year.
Intervention code [1] 264239 0
Not applicable
Comparator / control treatment
uncontrolled study - the two study groups will be reviewed independently
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262353 0
temperature measurement utilising tympanic, temporal artery, rectal and oral thermometry
Timepoint [1] 262353 0
arrival in the emergency department
Secondary outcome [1] 273613 0
nil
Timepoint [1] 273613 0
nil

Eligibility
Key inclusion criteria
emergency department patients requiring temperature measurement
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
# greater than 3months of age to 18 years of age
# Patients with any medical condition that contraindicates the use of rectal, tympanic or temporal artery thermometer.
# Infants who are receiving chemotherapy, are immunocompromised or have rectal trauma infections or anomalies.
# Patients who are too ill to have multiple temperature assessments.
#Patients /Parents/guardians who are unable to give informed consent.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264688 0
Hospital
Name [1] 264688 0
Peninsula Health
Country [1] 264688 0
Australia
Primary sponsor type
Hospital
Name
Frankston Hospital
Address
Hastings Road
Frankston
Victoria 3199
Country
Australia
Secondary sponsor category [1] 263821 0
None
Name [1] 263821 0
Address [1] 263821 0
Country [1] 263821 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266681 0
Peninsula Health
Ethics committee address [1] 266681 0
Hastings Road
Frankston
Vic 3199
Ethics committee country [1] 266681 0
Australia
Date submitted for ethics approval [1] 266681 0
18/03/2011
Approval date [1] 266681 0
Ethics approval number [1] 266681 0

Summary
Brief summary
This study will compare temperature measurements of an adult and small infant population in the emergency department to determine which technique provides the best indicator for detection of fever. The aim is to evaluate the accuracy and effectiveness of tympanic and infrared skin thermometers compared to rectal temperature in infants and oral temperature in adults in the emergency department.
The findings will aid in the development of a consistent, evidence based approach to temperature measurement in Frankston Hospital Emergency patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32355 0
Address 32355 0
Country 32355 0
Phone 32355 0
Fax 32355 0
Email 32355 0
Contact person for public queries
Name 15602 0
Associate Professor Pamela Rosengarten
Address 15602 0
Emergency Department
Frankston Hospital
Hastings Road
Frankston
Victoria 3199
Country 15602 0
Australia
Phone 15602 0
+61 3 97847177
Fax 15602 0
Email 15602 0
[email protected]
Contact person for scientific queries
Name 6530 0
Associate Professor Pamela Rosengarten
Address 6530 0
Emergency Department
Frankston Hospital
Hastings Road
Frankston
Victoria 3199
Country 6530 0
Australia
Phone 6530 0
+61 3 97847177
Fax 6530 0
Email 6530 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.