Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000448448
Ethics application status
Approved
Date submitted
27/05/2015
Date registered
6/04/2016
Date last updated
6/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observation of perioperative temperature changes in patients undergoing surgery for femur neck fracture
Scientific title
An observation of perioperative temperature changes in patients undergoing surgery for femur neck fracture
Secondary ID [1] 286478 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypothermia 294665 0
Condition category
Condition code
Surgery 294967 294967 0 0
Other surgery
Anaesthesiology 294968 294968 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Around 80 adult patients undergoing surgery for fractured neck of femur during the 3 month study period will be chosen for. observation. They will have their temperature measured by tympanic thermometer at different time points from their arrival at operating theatre until they reach the post anaesthesia care unit following their surgery. The temperatures will be measured in the holding bay, operating theatre and in the post anaesthesia care unit. Temperatures on arrival and departure from each station will be recorded along with details of patient, surgery and anaesthesia as per the audit form. The warming methods currently practised in the operating theatre will not be interfered with. A note will be made of the warming measures utilized perioperatively. Length of stay in the recovery room will be recorded. Tympanic thermometer will be used for the study.
Intervention code [1] 291564 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294723 0
Temperature measured during different time points by the use of tympanic thermometer
Timepoint [1] 294723 0
At different time points: in the theatre holding bay, during the procedure in the operating theatre, in the recovery room, namely on arrival at holding bay, before induction of anaesthesia, every 30 minutes until departure from operating room, arrival at recovery room and 30 minutes thereafter until departure to ward
Secondary outcome [1] 313930 0
Prevalence of hypothermia in the target population assessed with tympanic thermometer
Timepoint [1] 313930 0
Various time points through the procedure, namely in the theatre holding bay, during the procedure in the operating theatre, in the recovery room, namely on arrival at holding bay, before induction of anaesthesia, every 30 minutes until departure from operating room, arrival at recovery room and 30 minutes thereafter until departure to ward
Secondary outcome [2] 313931 0
Postoperative length of stay in the recovery room as assessed by review of medical records
Timepoint [2] 313931 0
Recovery room stay following surgery

Eligibility
Key inclusion criteria
All adult patients undergoing surgery for fractured neck of femur.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For hypothermic subjects, a temperature difference of 0.2 degree celsius between any time point is considered clinically significant. Hypothermia is defined as temperature < 36 degree Celsius. Prevalence of hypothermia will be calculated at different time points based on the formula: (n with hypothermia/sample n) x 100%.
Sample size was estimated based on expected medium effect size (0.5), using Cohen’s convention values. An a level of 0.05 was selected, with a power level of 0.80. Based on the subjects acting as their own controls, these values determined the sample size estimate of n = 63. With 20% loss, the number of patients recruited is planned be 75.
Data analysis will be performed using SPSS (version 21) and will use descriptive statistics to summarise demographic and baseline patient characteristics of the sample. Continuous variables (i.e. time-based temperatures) will be summarised with means, standard deviations, with confidence intervals set at 95%. Within group differences will be examined using parametric tests of difference (T-test, ANOVA; provided distribution assumptions are met) i.e. mean differences in outcome measures (temperature) between groups at different time points. Repeated measures ANOVA will be used to investigate differences (in temperature) over time. Differences in length of stay in the recovery room will be examined using t-test, to compare differences at different temperature-change cut-off points. Significance will be set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/12/2013
Date of last participant enrolment
Anticipated
Actual
15/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3657 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 9489 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 291042 0
Self funded/Unfunded
Name [1] 291042 0
Country [1] 291042 0
Primary sponsor type
Individual
Name
Dr.Usha Gurunathan
Address
The Prince Charles HOspital, Rode Road,Chermside, QLD 4032
Country
Australia
Secondary sponsor category [1] 289725 0
None
Name [1] 289725 0
Address [1] 289725 0
Country [1] 289725 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292626 0
Human Research Ethics Committee, Metro North Hospital and Health SErvice
Ethics committee address [1] 292626 0
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Ethics committee country [1] 292626 0
Australia
Date submitted for ethics approval [1] 292626 0
Approval date [1] 292626 0
30/09/2013
Ethics approval number [1] 292626 0
HREC/13/QPCH/247

Summary
Brief summary
Unintended perioperative hypothermia, defined as a core body temperature less than 36 degree celsius is not uncommon in elderly surgical patient. In the operating theatre, a combination of altered thermoregulatory mechanisms induced by anaesthesia and cooler ambient temperatures cause a decrease in core temperature.Unintended perioperative hypothermia can result in increased complications such increased surgical site infection, adverse cardiovascular events, delayed recovery from anaesthesia, increased surgical bleeding, impaired immune function, prolonged recovery room stay and hospitalization and increased costs. Different modalities of warming patients have been suggested such as forced air warmers or Bair Huggers, warming intravenous fluids, pre-warming patients from 30 minutes before surgery, warmed cotton blankets, but on many occasions, they have not been very effectively used resulting in unintended hypothermia. Elderly patients are more prone to hypothermia because of increase in frailty, comorbidities, impaired thermoregulation with age. In the current study, we aim to study the changes to the body temperature in patients undergoing hip fracture surgery through the perioperative course .
Trial website
Trial related presentations / publications
No publications yet
Public notes

Contacts
Principal investigator
Name 42254 0
Dr Usha Gurunathan
Address 42254 0
The Prince Charles Hospital, Rode Road, Chermside, Queensland- 4032
Country 42254 0
Australia
Phone 42254 0
+61 7 3139 4000
Fax 42254 0
Email 42254 0
usha.gurunathan@health.qld.gov.au
Contact person for public queries
Name 42255 0
Dr Usha Gurunathan
Address 42255 0
The Prince Charles Hospital, Rode Road Chermside, Queensland - 4032
Country 42255 0
Australia
Phone 42255 0
+61 7 3139 4000
Fax 42255 0
Email 42255 0
usha.gurunathan@health.qld.gov.au
Contact person for scientific queries
Name 42256 0
Dr Usha Gurunathan
Address 42256 0
The Prince Charles Hospital, Rode Road, Chermside, Queensland,4032
Country 42256 0
Australia
Phone 42256 0
+61 7 3139 4000
Fax 42256 0
Email 42256 0
usha.gurunathan@health.qld.gov.au

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No Supporting Document Provided



Results publications and other study-related documents

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