Trial Review

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
ACTRN12612000803897
Ethics application status
Approved
Date submitted
30/07/2012
Date registered
1/08/2012
Date last updated
1/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of core and peripheral temperature measurement in adult critically ill patients with acute brain injury and sepsis
Scientific title
Comparison of intravesical core temperature measurement via a temperature sensing bladder catheter with peripheral temperatures measured at tympanic, nasopharyngeal and axillary sites in critically ill adult patients with acute brain injury and sepsis.
Secondary ID [1] 280913 0
Nil
Universal Trial Number (UTN)
Trial acronym
CELSIUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 286992 0
Cardiac arrest 286993 0
Stroke 287039 0
Sepsis 287040 0
Condition category
Condition code
Stroke 287325 287325 0 0
Ischaemic
Stroke 287326 287326 0 0
Haemorrhagic
Infection 287342 287342 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Two groups of temperature measurements (at least three hours apart) will be made on two consecutive study days.

The use of physical cooling (ice packs or cooling blankets), renal replacement therapy and nasal devices including nasogastric tubes, nasal intubation, high flow nasal prongs or nasal prongs will be recorded with each group of temperature measurements. Total daily urine output and serum creatinine will be recorded for each of the two study days on which temperature measurements are made.

The equipment used for measuring temperature will be the Braun Thermoscan Type 6021 for tympanic measurements, the Protec BX/144 digital thermometer for axillary measurements, the General Electric Vital-Temp general-purpose probe for nasopharyngeal measurements, and the Nellcor Mon-a-therm Foley Temp 400 series for intravesical measurements.

Temperature will be measured at each site as follows:

a. Tympanic- an ear-tug will be performed by pulling the pinna upward and backward whilst inserting the probe with a slight rotating motion aiming towards the anterior inferior third of the tympanic membrane. To prevent interference from the air temperature, the probe should penetrate at least one third of the external auditory meatus and form a seal. If the patient wears a hearing aid, this will be removed for 20 minutes prior to measurement. Similarly if the patient has been lying in a lateral position, they will be laid supine at least 20 minutes prior to measurement to avoid ear-warming. Paired measurements will be taken in both the right and left ears and averaged.

b. Axillary- the thermometer will be placed on dry skin deep into the apex of the axilla with the patient’s arms adducted so that the tip of the thermometer is covered by the arm to prevent interference from air temperature. Paired measurements will be taken in both the right and left axillae and averaged.

c. Nasopharyngeal- the probe will be positioned in the nasopharynx posterior to the soft palate by inserting approximately 10cm into the left or right nostril. The probe should be in situ for at least 20 minutes prior to measurement to allow for temperature to equilibrate. Patients with clinical or radiological evidence of base of skull or facial fractures will not have a nasopharyngeal probe inserted due to the risk of incorrect positioning.

d. Intravesical- the temperature sensing urinary catheter will be inserted as for a standard urinary catheter. The catheter should be in situ for at least 20 minutes prior to measurement to allow for temperature to equilibrate.

After the cessation of physical cooling, at least 20minutes should be allowed to pass before temperature measurement to allow for temperature to equilibrate.
Intervention code [1] 285348 0
Not applicable
Comparator / control treatment
Intravesical core temperature measured via a temperature sensing urinary catheter.
Control group
Active

Outcomes
Primary outcome [1] 287613 0
We will analyse our temperature data using the Bland-Altman method for agreement studies, which enables comparison of two measurements made using different instruments to calculate a 'mean difference' (accuracy). The standard deviation indicates the precision of the instrument, and the mean difference plus or minus 1.96 of the standard deviation gives the upper and lower limits of agreement which gives an interval within which we can be reasonably confident that the true value of the measurement lies within.

The primary analysis will use data from all of the patients; a second analysis will be done that includes the measurements that were taken during the use of physical cooling and within four hours of the cessation of physical cooling or active warming.
Timepoint [1] 287613 0
Four sets of temperature measurements over two days, each set taken at least 3 hours apart. Each set consists of tympanic measurements in both ears, axillary measurements in both axillae, nasopharyngeal and intravesical measurements.
Secondary outcome [1] 298530 0
Nil
Timepoint [1] 298530 0
Nil

Eligibility
Key inclusion criteria
Either:

1. Mechanically ventilated patients admitted into the intensive care units with a traumatic brain injury, cardiac arrest or stroke within the first week of intensive care treatment following injury

Or:

2. Patients admitted with sepsis (body temperature greater or equal to 38.0 degrees Celsius and receiving antimicrobial therapy for a known or suspected infection) within the first week of intensive care treatment for sepsis
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients under 16 years of age.

2. Patients for which informed consent is not provided from the patient or patient’s surrogate decision maker,(unless the ethics committee agree to waiving consent).

3. Patients for whom insertion (or replacement) of a urinary catheter is contraindicated (for example known history of urethral stricture of severe pelvic trauma with suspected urethral tear).

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4424 0
New Zealand
State/province [1] 4424 0
Wellington

Funding & Sponsors
Funding source category [1] 285706 0
Self funded/Unfunded
Name [1] 285706 0
Dr Manoj Saxena
Country [1] 285706 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Intensive Care Unit
St George Hospital
Gray Street, Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 284532 0
University
Name [1] 284532 0
The University of New South Wales
Address [1] 284532 0
The University of New South Wales
Sydney NSW 2052
Country [1] 284532 0
Australia
Other collaborator category [1] 276980 0
Individual
Name [1] 276980 0
Dr Paul Young
Address [1] 276980 0
The Wellington Regional Hospital
Riddiford Street, Newtown, Wellington 6021
Country [1] 276980 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287694 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 287694 0
Level 3, James Laws House
St George Public Hospital
Gray Street, Kogarah NSW 2217
Ethics committee country [1] 287694 0
Australia
Date submitted for ethics approval [1] 287694 0
Approval date [1] 287694 0
22/03/2012
Ethics approval number [1] 287694 0
HREC/12/STG/6

Summary
Brief summary
The CELSIUS Study is a prospective observational study of temperature measurement in critically ill patients with acute brain injury and sepsis in Australia and New Zealand.
In these patients we are evaluating commonly used methods of temperature measurement (tympanic, axillary, nasopharyngeal) with assessment against a pragmatic gold standard of urinary bladder temperature (intravesical) measurement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34485 0
Address 34485 0
Country 34485 0
Phone 34485 0
Fax 34485 0
Email 34485 0
Contact person for public queries
Name 17732 0
Dr Manoj Saxena
Address 17732 0
Intensive Care Unit
St George Hospital
Gray Street, Kogarah NSW 2217
Country 17732 0
Australia
Phone 17732 0
+61 2 9113 3373
Fax 17732 0
Email 17732 0
[email protected]
Contact person for scientific queries
Name 8660 0
Dr Manoj Saxena
Address 8660 0
Intensive Care Unit
St George Hospital
Gray Street, Kogarah NSW 2217
Country 8660 0
Australia
Phone 8660 0
+61 2 9113 3373
Fax 8660 0
Email 8660 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.