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Trial registered on ANZCTR


Registration number
ACTRN12610000591055
Ethics application status
Approved
Date submitted
21/07/2010
Date registered
21/07/2010
Date last updated
21/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of preoperative warming and/or warmed irrigation fluids on elective arthroscopic shoulder surgery patients' temperature, thermal comfort, and total recovery time: A randomised controlled trial.
Scientific title
In adult elective arthroscopic shoulder surgery patients does preoperative warming, warmed irrigation fluids, or a combination of both have beneficial effects on temperature, thermal comfort, and total recovery time compared to usual care.
Secondary ID [1] 252260 0
n/a
Universal Trial Number (UTN)
U1111-1116-1694
Trial acronym
Temperature and Comfort Study (TaCS).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadvertent perioperative hypothermia. 257778 0
Condition category
Condition code
Anaesthesiology 257950 257950 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: Participants will be warmed preoperatively for 45 minutes using a forced air warming device (brand name 'Bair Hugger') set at 43 degrees Celsius high fan. A lower body warming blanket will be applied over 50% of the anterior body surface. Irrigation fluids (used to irrigate the surgical site) will be warmed in a thermostatically controlled cabinet to a temperature of 38–40°C.

Intervention 2: Participants irrigation fluids (used to irrigate the surgical site) will be warmed in a thermostatically controlled cabinet to a temperature of 38–40°C.

Intervention 3: Participants will be warmed preoperatively for 45 minutes using a forced air warming device (brand name 'Bair Hugger') set at 43 degrees Celsius high fan. A lower body warming blanket will be applied over 50% of the anterior body surface.
Intervention code [1] 256845 0
Treatment: Devices
Intervention code [2] 256846 0
Treatment: Other
Intervention code [3] 256848 0
Prevention
Comparator / control treatment
Participants will receive ‘usual care’. This does not include preoperative warming or the use of warmed irrigation fluids. Both intervention and control groups will receive active intra-operative warming, as is the current routine practice.
Control group
Active

Outcomes
Primary outcome [1] 258821 0
Temperature measured with a tympanic thermometer.
Timepoint [1] 258821 0
On admission; prior to induction; on arrival to recovery; 20 min post arrival in recovery; on discharge from recovery.
Secondary outcome [1] 264909 0
Thermal comfort measured on a 10 point self-reported thermal comfort scale.
Timepoint [1] 264909 0
On admission; prior to induction; on arrival to recovery; 20 min post arrival in recovery; on discharge from recover.
Secondary outcome [2] 264910 0
Total recovery time.
Timepoint [2] 264910 0
Time starts on arrival to recovery unit and ends when patient is deemed fit for discharge based on their Post Anaesthetic Recovery (PAR) Score.

Eligibility
Key inclusion criteria
Elective arthroscopic shoulder surgery patient;
American Society of Anaesthesiologists (ASA) grade I-III;
Willing and able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body Mass Index (BMI) <18.5 or >40;
Preoperative temperature >37.5.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assessed for inclusion in the study and consented by a researcher not involved in administering the interventions or collecting outcome data. A researcher (off site) not involved in the patient recruitment process will be contacted by SMS to reveal treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher not involved in the study will generate a stratified block random sequence using a randomization computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257309 0
Hospital
Name [1] 257309 0
St Vincents & Mater Health Sydney nursing research grant
Country [1] 257309 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Private Hospital
Address
St Vincents Private Hospital, Victoria Street, Darlinghurst, NSW 2010
Country
Australia
Secondary sponsor category [1] 256554 0
None
Name [1] 256554 0
Address [1] 256554 0
Country [1] 256554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259336 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 259336 0
Ethics committee country [1] 259336 0
Australia
Date submitted for ethics approval [1] 259336 0
Approval date [1] 259336 0
24/06/2010
Ethics approval number [1] 259336 0
AU/16620/25224/1/181

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31413 0
Address 31413 0
Country 31413 0
Phone 31413 0
Fax 31413 0
Email 31413 0
Contact person for public queries
Name 14660 0
Jed Duff
Address 14660 0
Nursing Research Institute St Vincents & Mater Health Sydney Australian Catholic University (SV&MHS ACU), St Vincents Hospital, Level 5, deLacy building, Victoria St, Darlinghurst, NSW 2010
Country 14660 0
Australia
Phone 14660 0
+61 2 8382 4025
Fax 14660 0
+61 2 8382 3792
Email 14660 0
jduff@stvincents.com.au
Contact person for scientific queries
Name 5588 0
Prof Kim Walker
Address 5588 0
Nursing Research Institute SV&MHS ACU, St Vincents Hospital, Level 5, deLacy building, Victoria St, Darlinghurst, NSW 2010
Country 5588 0
Australia
Phone 5588 0
+61 2 8382 4032
Fax 5588 0
+61 2 8382 3792
Email 5588 0
kwalker@stvincents.com.au

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.