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Trial registered on ANZCTR


Registration number
ACTRN12616001631493
Ethics application status
Approved
Date submitted
22/11/2016
Date registered
25/11/2016
Date last updated
25/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Warm humidification for prevention of hypothermia during liver transplantation
Scientific title
Use Of Fisher & Paykel Humigard (Registered Trademark) Open Surgery Humidification System in The Prevention of Hypothermia in Patients Undergoing Orthotropic Liver Transplantation: A Prospective Randomized Pilot Clinical Trial
Secondary ID [1] 290586 0
None
Universal Trial Number (UTN)
U1111-1190-1169
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
liver transplantation 301045 0
Intraoperative hypothermia 301046 0
Condition category
Condition code
Surgery 300834 300834 0 0
Other surgery
Anaesthesiology 300835 300835 0 0
Other anaesthesiology
Oral and Gastrointestinal 300877 300877 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this study is the Humigard (Registered Trademark) system (Fisher and Paykel Healthcare, Auckland, New Zealand), which is a heat delivery system that allows insufflation of warm humidified CO2 into the open wound cavity.

The device works by delivering dry medical CO2 is at a flow rate of 10 L/min and a pressure of 4.5 bar from a medical pressurized gas cylinder (AGA gas AB, Stockholm, Sweden) via a polyvinyl chloride tube into an open surgery humidification system. It consists of a bacterial filter, and a humidification chamber filled with sterile water, positioned on a humidifier controller that includes an integrated temperature and flow sensor. The outlet of the humidification chamber is connected to a thermally insulated heated insufflation tube that maintains temperature and humidity of the gas to its outlet. The humidified and warm CO2 enters a gas diffuser (VITA-diffuser (Registered Trademark), Cardia Innovation AB, Stockholm, Sweden) consisting of a polyvinyl chloride tube with polyurethane foam at its end. The cylindrical polyurethane foam tip diverts the gas jet into multiple directions via the many small paths inside the foam. The gas is thus uniformly distributed and the large diffuser surface area greatly reduces the velocity of the outflow. The humidified gas is delivered directly into the surgical wound. The final temperature of the humidified CO2 is 37 degrees Celcius, with a 100% relative humidity.

Patients that will be receiving this intervention are adult patients undergoing liver transplantation in university teaching hospital.

The sterile device is placed into the open abdominal cavity by the surgeon at commencement of the transplant. The device remains in situ until closure of the surgical wound at completion of surgery. The device settings do not change at any point and the humidification is delivered continuously.

In addition to this device, all patients will also receive standard temperature homeostasis.
This will include:
1. Pre-warming with a full body warming blanket (Bair Hugger 3M 'Trademark', Model 315) set at 43oC one hour prior to surgery.
2. Ambient operating room temperature set at 21oC
3. Underbody warming blanket (Bair Hugger 3M, Model 637) set at 43oC, placed over a standard operating table. These warming blanket devices will be continued during induction of anaesthesia and during insertion of all invasive monitoring lines, after which the full body warming blanket will be replaced with an intraoperative upper body warming device that covers both upper limbs and face (Bair Hugger 3M 'Trademark', Model 523XL) for the remainder of the case.
4. During the anhepatic phase, ambient operating temperature will be increased to 23oC, with no further adjustments for the remainder of the case.
5. Temperature of all fluids delivered will be via a Belmont (Registered Trademark) Rapid Infuser RI-2 system that will deliver preheated fluids at 42oC.
Intervention code [1] 296449 0
Treatment: Devices
Comparator / control treatment
The control group will have the Humigard (Registered Trademark) system (Fisher and Paykel Healthcare, Auckland, New Zealand) placed in to the abdominal cavity as for the Intervention group, however the device will not be turned on.

All patients will also receive standard temperature homeostasis as the Interventional group. This will include:
1. Pre-warming with a full body warming blanket (Bair Hugger 3M 'Trademark', Model 315) set at 43oC one hour prior to surgery.
2. Ambient operating room temperature set at 21oC
3. Underbody warming blanket (Bair Hugger 3M 'Trademark', Model 637) set at 43oC, placed over a standard operating table. These warming blanket devices will be continued during induction of anaesthesia and during insertion of all invasive monitoring lines, after which the full body warming blanket will be replaced with an intraoperative upper body warming device that covers both upper limbs and face (Bair Hugger 3M 'Trademark', Model 523XL) for the remainder of the case.
4. During the anhepatic phase, ambient operating temperature will be increased to 23oC, with no further adjustments for the remainder of the case.
5. Temperature of all fluids delivered will be via a Belmont (Registered Trademark) Rapid Infuser RI-2 system that will deliver preheated fluids at 42oC.
Control group
Placebo

Outcomes
Primary outcome [1] 300251 0
Core temperature prior to reperfusion of the donor liver
Timepoint [1] 300251 0
This will be measured five minutes immediately prior to reperfusion of the donor liver (Stage 3-5min). Measurement of core temperature will be measured using a nasopharyngeal temperature probe (CareFusion Incorporation, Australia) inserted between 9 and 11 cm from the nares to maximize the likelihood of positioning in the upper third of the nasopharynx. As the insertion of a continuous Cardiac Output Swan-Ganz pulmonary artery catheter (Edward Lifesciences CCO-Combo, IL, USA) is part of our standard anaesthesia technique for all patients undergoing OLT, we will also use temperature measurements from the Pulmonary artery catheter.

Secondary outcome [1] 329498 0
Core temperature at Stage 1+60min
Timepoint [1] 329498 0
This will be measured at Stage 1+60min: (recorded 60 min after start of the dissection phase.

Measurement of core temperature will be measured using a nasopharyngeal temperature probe (CareFusion Incorporation, Australia) inserted between 9 and 11 cm from the nares to maximize the likelihood of positioning in the upper third of the nasopharynx. As the insertion of a continuous Cardiac Output Swan-Ganz pulmonary artery catheter (Edward Lifesciences CCO-Combo, IL, USA) is part of our standard anaesthesia technique for all patients undergoing OLT, we will also use temperature measurements from the Pulmonary artery catheter.
Secondary outcome [2] 329499 0
Core temperature at Stage 2+30 min
Timepoint [2] 329499 0
This will be measured at Stage 2+30 min (recorded 30 min after start of the anhepatic phase)

Measurement of core temperature will be measured using a nasopharyngeal temperature probe (CareFusion Incorporation, Australia) inserted between 9 and 11 cm from the nares to maximize the likelihood of positioning in the upper third of the nasopharynx. As the insertion of a continuous Cardiac Output Swan-Ganz pulmonary artery catheter (Edward Lifesciences CCO-Combo, IL, USA) is part of our standard anaesthesia technique for all patients undergoing OLT, we will also use temperature measurements from the Pulmonary artery catheter.
Secondary outcome [3] 329500 0
Core temperature at Stage 3+5min
Timepoint [3] 329500 0
This will be measured at Stage 3+5min: (recorded 5 min post reperfusion)

Measurement of core temperature will be measured using a nasopharyngeal temperature probe (CareFusion Incorporation, Australia) inserted between 9 and 11 cm from the nares to maximize the likelihood of positioning in the upper third of the nasopharynx. As the insertion of a continuous Cardiac Output Swan-Ganz pulmonary artery catheter (Edward Lifesciences CCO-Combo, IL, USA) is part of our standard anaesthesia technique for all patients undergoing OLT, we will also use temperature measurements from the Pulmonary artery catheter.
Secondary outcome [4] 329501 0
Core temperature at Stage 3+60min
Timepoint [4] 329501 0
This will be measured at Stage 3+60min: (recorded 60 min post reperfusion)

Measurement of core temperature will be measured using a nasopharyngeal temperature probe (CareFusion Incorporation, Australia) inserted between 9 and 11 cm from the nares to maximize the likelihood of positioning in the upper third of the nasopharynx. As the insertion of a continuous Cardiac Output Swan-Ganz pulmonary artery catheter (Edward Lifesciences CCO-Combo, IL, USA) is part of our standard anaesthesia technique for all patients undergoing OLT, we will also use temperature measurements from the Pulmonary artery catheter.
Secondary outcome [5] 329502 0
Core temperature at surgical closure of the wound
Timepoint [5] 329502 0
This will be measured during closure of the surgical wound

Measurement of core temperature will be measured using a nasopharyngeal temperature probe (CareFusion Incorporation, Australia) inserted between 9 and 11 cm from the nares to maximize the likelihood of positioning in the upper third of the nasopharynx. As the insertion of a continuous Cardiac Output Swan-Ganz pulmonary artery catheter (Edward Lifesciences CCO-Combo, IL, USA) is part of our standard anaesthesia technique for all patients undergoing OLT, We will also use temperature measurements from the Pulmonary artery catheter.

Eligibility
Key inclusion criteria
Inclusion criteria will include:
1. adult patients (age greater than 18 years)
2. undergoing primary orthotopic liver transplantation (OLT)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes:
1. pregnancy
2. fulminant hepatic failure
3. redo-OLT
4. requirements for continuous vena-venous bypass
5. requirements for haemofiltration
6. multivisceral transplantation

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)
All adult patients scheduled to be undergoing liver transplantation in the operating suite of the Austin Hospital will be screened for eligibility. Once informed consent has been obtained, randomisation will be by means of sealed opaque envelopes with permuted blocks of variable size. Each envelope will contain a study arm allocation with the Active device or placebo device.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used using computer generated software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Samples size calculations will be performed using inferences for means comparing two independent samples. This was established with an internal audit of 60 anaesthesia charts of patients undergoing OLT in our institution over the previous 2 years, which demonstrated a mean (standard deviation) temperature prior to reperfusion of 35.4oC (0.8). Nominating a clinically important difference of 1oC in the intervention group, using a two-sided test, with an alpha value of 0.05 and a desired power of 0.80, the sample size required for each group was 11 participants.

Continuous data will be tested for normality using the D’Agnostino-Pearson omnibus test. For the primary end point between groups, comparisons for continuous data will be performed with the use of Students’s t-test. All test will be considered two-tailed and a p-value <0.05 will indicate statistical significance. Values will be reported as mean and standard deviation (SD) or medians and interquartile range (IQR). Changes in NPP and PAC temperatures over the given time points will be measured with repeated measures ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
1/01/2014
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
22
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295025 0
Hospital
Name [1] 295025 0
Austin Hospital
Country [1] 295025 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
152 Studley Road, Heidelberg, Victoria, 3084, Australia
Country
Australia
Secondary sponsor category [1] 293842 0
None
Name [1] 293842 0
Address [1] 293842 0
Country [1] 293842 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296380 0
Austin Research Ethics Committee
Ethics committee address [1] 296380 0
152 Studley Road, Heidelberg, Victoria, 3084, Australia
Ethics committee country [1] 296380 0
Australia
Date submitted for ethics approval [1] 296380 0
10/05/2012
Approval date [1] 296380 0
26/07/2012
Ethics approval number [1] 296380 0
HREC no: 2012/04674

Summary
Brief summary
The Victorian Liver Transplantation Unit at Austin Hospital is a collaborative service providing liver transplant services to residents in Victoria, Australia. Retrospective intra-operative data collection from our institution shows that 72% of patients undergoing liver transplantation are hypothermic prior to reperfusion of the donor liver, despite intense and standardised measures taken to maintain temperature homeostasis. This study is a prospective, single centre, blinded, randomised pilot trial to test the feasibility and efficacy of whether, in addition to the standard temperature measure undertaken to prevent intra-opeartive hypothermia, the additional use of the Fisher & Paykel Humigard (Registered Trademark) Open Surgery Humidification System will prevent hypothermia in adult patients undergoing orthotopic liver transplantation. Adult patients undergoing orthotopic liver transplantation will be included. The primary end point will be core temperature measured five minutes immediately prior to reperfusion of the donor liver.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 70626 0
A/Prof Laurence Weinberg
Address 70626 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 70626 0
Australia
Phone 70626 0
+61394965000
Fax 70626 0
+61394966421
Email 70626 0
[email protected]
Contact person for public queries
Name 70627 0
Laurence Weinberg
Address 70627 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 70627 0
Australia
Phone 70627 0
+61394965000
Fax 70627 0
+61394966421
Email 70627 0
[email protected]
Contact person for scientific queries
Name 70628 0
Laurence Weinberg
Address 70628 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 70628 0
Australia
Phone 70628 0
+61394965000
Fax 70628 0
+61394966421
Email 70628 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
SourceTitleYear of PublicationDOI
Dimensions AIPrevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial2017https://doi.org/10.1186/s12893-017-0208-z
N.B. These documents automatically identified may not have been verified by the study sponsor.