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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.
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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.
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Secondary ID [1]
252260
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n/a
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Universal Trial Number (UTN)
U1111-1116-1694
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Trial acronym
Temperature and Comfort Study (TaCS).
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inadvertent perioperative hypothermia.
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Condition category
Condition code
Anaesthesiology
257950
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0
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Other anaesthesiology
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
256845
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Treatment: Devices
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Temperature measured with a tympanic thermometer.
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Assessment method [1]
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Timepoint [1]
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On admission; prior to induction; on arrival to recovery; 20 min post arrival in recovery; on discharge from recovery.
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Secondary outcome [1]
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Thermal comfort measured on a 10 point self-reported thermal comfort scale.
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Assessment method [1]
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Timepoint [1]
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On admission; prior to induction; on arrival to recovery; 20 min post arrival in recovery; on discharge from recover.
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Secondary outcome [2]
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Total recovery time.
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Assessment method [2]
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Timepoint [2]
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Time starts on arrival to recovery unit and ends when patient is deemed fit for discharge based on their Post Anaesthetic Recovery (PAR) Score.
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Eligibility
Key inclusion criteria
Elective arthroscopic shoulder surgery patient;
American Society of Anaesthesiologists (ASA) grade I-III;
Willing and able to give informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Body Mass Index (BMI) <18.5 or >40;
Preoperative temperature >37.5.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St Vincents & Mater Health Sydney nursing research grant
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Address [1]
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St Vincents Hospital, Victoria Street, Darlinghurst, NSW 2010
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
St Vincents Private Hospital
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Address
St Vincents Private Hospital, Victoria Street, Darlinghurst, NSW 2010
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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St Vincents Hospital Human Research Ethics Committee
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Ethics committee address [1]
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Research Officer, Level 6 deLacy Building, St Vincents Hospital, Victoria Street, Darlinghurst, NSW 2010
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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24/06/2010
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Ethics approval number [1]
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AU/16620/25224/1/181
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Summary
Brief summary
In this study we aim to investigate the effects of preoperative warming and/or warmed irrigation fluid on temperature control, thermal comfort, and post-anaesthetic recovery time in patients undergoing elective arthroscopic shoulder surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jed Duff
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Address
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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
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Country
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Australia
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Phone
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+61 2 8382 4025
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Fax
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+61 2 8382 3792
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Kim Walker
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Address
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Nursing Research Institute SV&MHS ACU, St Vincents Hospital, Level 5, deLacy building, Victoria St, Darlinghurst, NSW 2010
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Country
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Australia
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Phone
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+61 2 8382 4032
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Fax
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+61 2 8382 3792
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Email
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[email protected]
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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.
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