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Trial registered on ANZCTR


Registration number
ACTRN12614000953639
Ethics application status
Approved
Date submitted
29/08/2014
Date registered
5/09/2014
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the WarmCloud and Under body Bair Hugger for maintaining core temperature during liver transplantation
Scientific title
Comparison of the WarmCloud and BairHugger for preventing intraoperative hypothermia in patients undergoing orthotopic liver transplantation
Secondary ID [1] 285244 0
Nil
Universal Trial Number (UTN)
U1111-1160-9729
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Transplantation 292880 0
Condition category
Condition code
Surgery 293173 293173 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the Kanmed WarmCloud as an underbody intraoperative warming device. This differs from the comparator (Bair Hugger) which is also an underbody warming blanket in a couple of important ways. Firstly the Bair Hugger has holes in the blanket allowing convection currents to flow around the patient. The WarmCloud has no holes and lifts the patient up (Like a LiLo) relying more on conduction. In lifting the patient up it also provides a greater contact area (as the patient's weight on the BairHugger occludes some of the holes) and provides some pressure relief.
The device is to be used for the entire duration of the surgery and will be set at 42 degrees. If core temperature hits 37.0 it will be reduced to 32 and if core temperature hits 37.5 it will be reduced to 22. The pressure settings will be start at 30 cm H2o and adjusted to weight.
Intervention code [1] 290125 0
Treatment: Devices
Comparator / control treatment
Bair Hugger underbody warming blanket
The description is above.
It will be used for the entirety of the surgical procedure.
It will be set to 43 degrees initially. If temp hits 37 it will be reduced to 32 degrees and if temp hits 37.5 or above to ambient temperature.
Control group
Active

Outcomes
Primary outcome [1] 293037 0
Nasopharyngeal temperature (assessed using a naso-pharyngeal temperature probe)
Timepoint [1] 293037 0
Prior to Reperfusion of the liver
Secondary outcome [1] 310219 0
Pulmonary Artery Catheter Temperature (as measured by the thermistor on a pulmonary artery catheter)
Timepoint [1] 310219 0
Prior to reperfusion
Secondary outcome [2] 310220 0
Nasopharyngeal Temperature (assessed using a naso-pharyngeal temperature probe)
Timepoint [2] 310220 0
At Closure
Two hours after incision
Secondary outcome [3] 310248 0
Pulmonary artery catheter temp (as measured by the thermistor on a pulmonary artery catheter)
Timepoint [3] 310248 0
At Closure
2 hours after incision
Secondary outcome [4] 310249 0
nasopharyngeal temperature (assessed using a naso-pharyngeal temperature probe)
Timepoint [4] 310249 0
Average throughout case (from induction of anaesthesia until transfer to Post-anaesthesia care unit)
Secondary outcome [5] 310250 0
Pulmonary artery catheter temperature (as measured by the thermistor on a pulmonary artery catheter)
Timepoint [5] 310250 0
Average throughout case (from induction of anaesthesia until transfer to Post-anaesthesia care unit)

Eligibility
Key inclusion criteria
Patients undergoing Orthotopic Liver Transplantation at the Austin Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients going to theatre directly from Critical Care
Patients needing extracorporeal circuits for CVVH or Veno-venous bypass

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Waiver of consent has been issued by HREC
Attempt to get all comers
Allocation is by unmarked opaque sealed enveloped which are shuffled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Shuffled and random selection of opaque sealed envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Calculation
From a previous study we have estimated that the standard distribution of temperatures prior to reperfusion is 0.41. A significant difference between groups would be 0.5. With an alpha level (p value) of 0.05, a beta value of 0.8, an estimated standard deviation of 0.41, and an estimated change in temperature of 0.5 degrees we would need a sample size of 26 patients.
To allow for data loss we aim to recruit 30 patients.
This sample size calculation is based on the primary outcome only

Statistical Analysis
We will use descriptive statistical terms to describe the demographics of our study group.
The Ryan-Joiner test will be used to check that the distribution of temperatures are normally distributed. If normally distributed, unpaired t tests will be used to compare the two groups. In the event that these variables are not normally distributed then a Wilcoxon signed rank test will be used. As well as the p value, the mean change and 95% confidence intervals will be reported for normally distributed variables, median and inter-quartile range for non-parametric variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2014
Actual
8/09/2014
Date of last participant enrolment
Anticipated
8/09/2015
Actual
1/01/2016
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2934 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 8649 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289873 0
Hospital
Name [1] 289873 0
Anaesthesia Research Fund (Austin Hospital)
Country [1] 289873 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Rd
Heidelberg, Vic 3084
Country
Australia
Secondary sponsor category [1] 288553 0
None
Name [1] 288553 0
Address [1] 288553 0
Country [1] 288553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291595 0
Austin Hospital HREC
Ethics committee address [1] 291595 0
Human Research Ethics Committee
Office for Research, Level 8 HSB.
Austin Hospital
145 Studley Rd
Heidelberg, Vic 3084
Ethics committee country [1] 291595 0
Australia
Date submitted for ethics approval [1] 291595 0
23/06/2014
Approval date [1] 291595 0
18/08/2014
Ethics approval number [1] 291595 0
LNR/14/Austin/306

Summary
Brief summary
To determine if the Kanmed WarmCloud reduces the incidence of hypothermia in patients when compared with the Bair Hugger warming system in patients undergoing a liver transplant
Trial website
Trial related presentations / publications
Transplant Direct. 2018 Mar 20;4(4):e358. doi: 10.1097/TXD.0000000000000775. eCollection 2018 Apr.
Comparison of the WarmCloud and Bair Hugger Warming Devices for the Prevention of Intraoperative Hypothermia in Patients Undergoing Orthotopic Liver Transplantation: A Randomized Clinical Trial.
Pearce B, Mattheyse L1, Ellard L2,3, Desmond F2, Pillai P2, Weinberg L2,3.
Public notes

Contacts
Principal investigator
Name 51034 0
Dr Brett Pearce
Address 51034 0
Anaesthetic Dept
Austin Hospital
145 Studley Rd
Heidelberg, Vic, 3084
Country 51034 0
Australia
Phone 51034 0
+61394965000
Fax 51034 0
Email 51034 0
[email protected]
Contact person for public queries
Name 51035 0
Brett Pearce
Address 51035 0
Anaesthetic Dept
Austin Hospital
145 Studley Rd
Heidelberg, Vic, 3084
Country 51035 0
Australia
Phone 51035 0
+61394965000
Fax 51035 0
Email 51035 0
[email protected]
Contact person for scientific queries
Name 51036 0
Brett Pearce
Address 51036 0
Anaesthetic Dept
Austin Hospital
145 Studley Rd
Heidelberg, Vic, 3084
Country 51036 0
Australia
Phone 51036 0
+61394965000
Fax 51036 0
Email 51036 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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