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Trial registered on ANZCTR


Registration number
ACTRN12617000850370
Ethics application status
Approved
Date submitted
30/05/2017
Date registered
8/06/2017
Date last updated
19/04/2022
Date data sharing statement initially provided
5/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating the effect of humidified warm carbon dioxide (CO2) insufflation during laparoscopic and open abdominal surgery.
Scientific title
A randomised controlled trial investigating the effect of humidified warm CO2 insufflation on body temperature loss during laparoscopic and open abdominal surgery.
Secondary ID [1] 292069 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Gastrointestinal (GI) Surgery 303477 0
Hepatobiliary (HPB) Surgery 303514 0
Condition category
Condition code
Surgery 302894 302894 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the use of warm humidified Carbon Dioxide (CO2) insufflation in Upper GI and HPB surgery. There are two study arms, each with two groups. Patients in each arm will be randomized into either one of the two groups.

Arm 1: Laparoscopic surgery
Arm 1 - Group 1: Warm humidified CO2
Arm1 - Group 2: Dry room temperature CO2 (standard of care)

Arm 2: Open surgery
Arm 2 - Group 1: Warm humidified CO2
Arm 2- Group 2: No intracorporeal warming

Warmed humidified CO2 will be delivered into open peritoneal cavity during open surgery, and use for insufflation of peritoneal cavity during laparoscopic surgery. This will be delivered to Group 1 of Arm 1 and 2 by operating surgeon in theatre.
Humidification device - HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand) will be used throughout the surgery session (from first incision until completion of surgery). CO2 gas will be warmed to 37 degrees Celsius and humidity will be at 100% RH.

An external warming device (upper body Bair Hugger) will be set to 38 degree Celsius and will be used on all participants. All fluids administered to the participants during the operation will be warmed using the BIEGLER medizin elektronik BW 585 warmer at 40 degree Celsius. Small 5x5mm excisional biopsies from the right paracolic will be taken at the start and just prior to the completion of the operation in the first 10 patients of each arm. These biopsy will then be analysed to identify any histological markers of inflammation.

All staff member involve in the surgery will be notify of the protocol requirements, in particular theatre technicians and anesthetists. Adherence will be maintained by implementation of checklists. A research coordinator will be employed to ensures that all parties involved adhere to the protocol.
Intervention code [1] 298207 0
Treatment: Devices
Comparator / control treatment
The use of warm humidified CO2 will be compared with standard of care.

For laparoscopic surgeries, insufflation is often done with dry room temperature CO2, which is the current standard of care. In open surgeries insufflations are not routinely done. For both operative approach, standard of care for intraoperative warming are forced air warming, upper body bair hugger and warming of intravenous infusions, blood products and irrigation fluids.
Control group
Active

Outcomes
Primary outcome [1] 302284 0
To determine if warm humidified CO2 during laparoscopic and open Upper GI/HPB surgery reduces temperature loss. Outcome will be measured using a nasopharyngeal temperature probe.
Timepoint [1] 302284 0
Intraoperative and postoperative body temperature will be measured at the beginning and at 15 minute intervals until the end of the operation.
Secondary outcome [1] 335353 0
To determine whether warm humidified CO2 insufflation gas reduces post-operative pain after laparoscopic and open Upper GI/HPB surgery of greater than 2 hour duration. Outcome will be assessed by postoperative pain questionnaire designed for the study, with incorporation of the 100mm visual analogue scale .
Timepoint [1] 335353 0
Pain assessment will be done postoperatively with pain questionnaire and 100mm visual analogue scale. This must be complete at 24 ± 4 hours postoperatively.
Secondary outcome [2] 335355 0
To define the histopathological changes which occur within the peritoneum during Upper GI/HPB surgery and how this is affected by warm humidified CO2 insufflation. This will be assessed by taking 2 small (5x5mm) biopsies of the peritoneum, at two time points (0 and 3 hours intraoperative). Biopsies will only be taken from the first 20 patients (10 from each arm).
Timepoint [2] 335355 0
Peritoneal biopsy will be taken intraoperative at the beginning and at the end of the surgery, Analysis of the tissue samples will be done postoperatively.

Eligibility
Key inclusion criteria
Patients undertaking elective Upper GI or HPB surgery of longer than 2 hours duration at St Vincent's Hospital, Melbourne.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are pregnant and the human fetus
- Children and/or young people (ie. <18 years)

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)
Potential participants are those undertaking Upper GI or HPB surgery at St Vincent’s Hospital, Melbourne. They will be participants who are having either laparoscopic or open surgery of greater than 2 hours duration.

Participants will be recruited at outpatient clinics and written consent will be obtained. They will also be given the opportunity to read through the patient information form, to listen from the researcher what the study is about and be able to ask questions prior to deciding whether to be involved in the study.

Eligible patients who consented to participate in the study will then be randomly allocated to treatment or control arm. Allocation concealment will be done by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed and results revealed on day of surgery. Simple randomization will be done using computerized sequence generation and concealment by sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be computed for all variables using means, standard deviations and percentiles for continuous factors and frequencies for categorical variables. These will be used to examine the distribution of study variables, to identify outliers, and to determine variable categorization. If necessary, temperature, as the primary outcome will be transformed to attain normality (as tested by q-q plots and sktest). Student’s t-test will be used to test for statistically significant differences between the Humidified group versus the conrols for open and laparoscopic surgical approaches separately. Differences in pain between groups will be assessed as a secondary outcome using Student’s t-test or Wilcoxon Rank Sum test as appropriate. Given the repeated measures to be taken of temperature, two distinct exploratory analyses will be undertaken to understand the patterns of temperature overall during surgery: 1) the AUC of temperature will be calculated and analyzed; and 2) a random effects mixed model will be estimated to understand longitudinal patterns of temperature change during surgery.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2017
Actual
13/07/2017
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
120
Accrual to date
96
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8220 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 16279 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 296601 0
Hospital
Name [1] 296601 0
St Vincent's Hospital Melbourne
Country [1] 296601 0
Australia
Funding source category [2] 304194 0
Hospital
Name [2] 304194 0
St Vincent's Hospital Melbourne Research Endowment Fund
Country [2] 304194 0
Australia
Primary sponsor type
Other Collaborative groups
Name
St Vincent's Hospital Melbourne HPB and Upper GI Research Group
Address
41 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 295557 0
None
Name [1] 295557 0
None
Address [1] 295557 0
None
Country [1] 295557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297828 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 297828 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 297828 0
Australia
Date submitted for ethics approval [1] 297828 0
Approval date [1] 297828 0
31/03/2017
Ethics approval number [1] 297828 0
HREC/16/SVHM/153

Summary
Brief summary
The current study aims to investigate the effect of using warm and humidified carbon dioxide (CO2) gas instead of cold dry CO2 (standard of care) during laparoscopic surgery, and the insufflation of warmed humidified CO2 during open abdominal surgery,

The Study will be a single blinded randomized controlled study and participants will be recruited from patients undertaking laparoscopic or open abdominal surgery.

Primary outcome will be the effect of using warm humidified CO2 insufflation gas on body temperature with histopathological changes to the peritoneum and post-operative pain being measured as secondary outcomes.

Clinical benefit will be assessed by measuring post-operative pain, using a post-operative pain questionnaire, temperature to assess for hypothermia and analyses of peritoneal biopsies taken at the beginning and just prior to conclusion of the operations. It is expected that warm and humidified CO2 will reduce hypothermia and peritoneal damage, and improve post-operative pain.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 75210 0
Mr Michael Hii
Address 75210 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy VIC 3065
Country 75210 0
Australia
Phone 75210 0
+61 3 9231 2211
Fax 75210 0
Email 75210 0
[email protected]
Contact person for public queries
Name 75211 0
Lynn Chong
Address 75211 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy VIC 3065
Country 75211 0
Australia
Phone 75211 0
+61 3 9231 2211
Fax 75211 0
Email 75211 0
[email protected]
Contact person for scientific queries
Name 75212 0
Michael Hii
Address 75212 0
St Vincent's Hospital Melbourne
41 Victoria Parade, Fitzroy VIC 3065
Country 75212 0
Australia
Phone 75212 0
+61 3 9231 2211
Fax 75212 0
Email 75212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5550Ethical approval    373038-(Uploaded-30-10-2019-13-49-21)-Study-related document.pdf



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.