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Trial registered on ANZCTR


Registration number
ACTRN12618000473268
Ethics application status
Approved
Date submitted
24/03/2018
Date registered
3/04/2018
Date last updated
3/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
MATCH - Myocardial de-Airing and Tissue preservation using carbon dioxide (CO2) with Humidification in patients undergoing open-chamber cardiac surgery
Scientific title
Effect of warm humidified carbon dioxide insufflation on pericardial tissue viability during open-chamber cardiac surgery. A randomized controlled trial.
Secondary ID [1] 293751 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MATCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open-chamber cardiac surgery 306133 0
Condition category
Condition code
Anaesthesiology 305248 305248 0 0
Other anaesthesiology
Surgery 306334 306334 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intraoperative pericardial insufflation of 100% CO2 at 37 degrees C and 100% humidity during open-chamber cardiac surgery will be performed with the HumiGard™ Surgical Humidification system with VITA-diffuser (Fisher & Paykel Healthcare, NZ) to warm and humidify the CO2 being delivered. The diffuser will be placed by the surgeon.
Intervention code [1] 300005 0
Treatment: Devices
Comparator / control treatment
Intraoperative pericardial insufflation of CO2 during open-chamber cardiac surgery will be performed with the Oxygen Catheter/Distal Eye (Unomedical, Conva Tec Limited UK), which delivers dry CO2. This is part of routine care.
Control group
Active

Outcomes
Primary outcome [1] 304403 0
Cellular viability of pericardial tissue. Defined as mesothelial cell morphology change with bulging and delamination (early signs of damage), exposed basal lamina (later signs of damage) using an an ordinal scale of 0-4 to grade severity of changes (0= 0-5%, 1= 6-25%, 2 = 26-50%, 3= 51-75%, 4 = >76%).
Timepoint [1] 304403 0
Pericardial biopsies (5x5x1mm) will be taken remote from the area of mechanical trauma due to retractors at two separate timepoints by the operating surgeon. Biopsy # 1: on opening of pericardium. Biopsy # 2: on closure of pericardium or at 2hrs post biopsy # 1 (whichever is earlier). The biopsies will be assessed by blinded observers.
Primary outcome [2] 305345 0
Microvilli damage calculated as % of normal remaining microvilli.
Timepoint [2] 305345 0
Pericardial biopsies (5x5x1mm) will be taken remote from the area of mechanical trauma due to retractors at two separate timepoints by the operating surgeon. Biopsy # 1: on opening of pericardium. Biopsy # 2: on closure of pericardium or at 2hrs post biopsy # 1 (whichever is earlier). The biopsies will be assessed by blinded observers.
Secondary outcome [1] 341838 0
Number of microemboli in the left atrium and proximal ascending aorta as assessed by transoesophageal echocardiogram (TOE) evaluation according to an ordinal scale:
0 - no bubbles detected
1 - few bubbles
2 - moderate number of bubbles
3 - large number of bubbles
Timepoint [1] 341838 0
During the following periods: From the release of the aortic cross clamp to the start of cardiac ejection, from cardiac ejection to finished de-airing. This will be assessed by the treating anaesthetist.
Secondary outcome [2] 341839 0
Cerebral oxygenation using near infrared spectroscopy (NIRS)
Timepoint [2] 341839 0
Baseline and lowest values during the procedure. The data will be collected by an independent observer.
Secondary outcome [3] 341840 0
De-airing time.
Timepoint [3] 341840 0
Starting at removal of aortic cross clamp and ending at the beginning of cardiac ejection. This will be recorded by an independent observer.
Secondary outcome [4] 341841 0
Highest cardiopulmonary bypass sweep speed used in order to maintain PaCO2 between 35-45 mmHg.
Timepoint [4] 341841 0
During cardiopulmonary bypass. The data will be collected by an independent observer at the end of the bypass period.
Secondary outcome [5] 341842 0
In-hospital complications, specifically death, cardio-respiratory arrest, cardiac events – infarction or ischaemia, wound dehiscence and device malfunction will be noted.
Timepoint [5] 341842 0
Collected from the discharge summary post-discharge by an independent observer.
Secondary outcome [6] 341843 0
Length of hospital stay from date of surgery to date of discharge.
Timepoint [6] 341843 0
Collected from medical records post-discharge by an independent observer.

Eligibility
Key inclusion criteria
Able to give informed consent
Scheduled for open-chamber cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking
Contraindications to transoesophageal probe insertion, including severe oesophageal disease
Emergency surgery

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)
Concealment will be achieved by the use of opaque envelopes opened at the beginning of surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted using random numbers obtained by a computer-based random number generator, in blocks of ten.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous unpublished laboratory mice study, minimal mesothelial damage (defined as less than or equal to 25% morphology change with bulging and delamination or grade 0 and 1 on the damage severity scale) occurs in 100% of the tissues that were exposed to warm and humidified CO2 insufflation, as opposed to 66% in the control group. A sample size estimation shows that with 80% power at the 0.05 level of significance, 20 patients are required in each group.

Data will be analysed using Fisher-exact test or Chi square test, depending on the size of data set, for categorical data. Unpaired two-tailed t-test or Mann Whitney U-test will be used to examine parametric data, depending on the normality of the data. A P value < 0.05 is considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/04/2018
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9723 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 18498 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 298364 0
Hospital
Name [1] 298364 0
Royal Melbourne Hospital
Country [1] 298364 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
The Royal Melbourne Hospital
300 Grattan St, Parkville
VIC 3050
Country
Australia
Secondary sponsor category [1] 297491 0
None
Name [1] 297491 0
Address [1] 297491 0
Country [1] 297491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299360 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299360 0
The Royal Melbourne Hospital
300 Grattan St
Parkville
VIC 3050
Ethics committee country [1] 299360 0
Australia
Date submitted for ethics approval [1] 299360 0
13/02/2018
Approval date [1] 299360 0
09/03/2018
Ethics approval number [1] 299360 0
HREC/18/MH/43

Summary
Brief summary
During open-heart surgery, gaseous micro-emboli (small gas bubbles) are commonly seen in the heart and bloodstream. This is thought to be associated with post-operative cognitive decline. To minimize this, it is common practice to insufflate the heart cavity with dry carbon dioxide (CO2) via a small tube. It is believed that CO2 causes less gaseous micro-emboli because it is denser and more soluble than air. However, dry and cold CO2 insufflation can cause tissue damage. A more sophisticated device, called the HumiGardTM system, is currently available in the market. It allows a continuous flow of warm and humidified CO2 to be insufflated via a gas diffuser into the heart cavity. In this study, we would like to test if warm and humidified CO2 will reduce the amount of tissue damage and also the number of micro-emboli travelling within the heart and to the brain, when compared to dry and cold CO2 insufflation.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2531 2531 0 0
/AnzctrAttachments/374279-2018.008 Ethics Approval.pdf (Ethics approval)
Attachments [2] 2532 2532 0 0
/AnzctrAttachments/374279-2018.008 Protocol V2.0 dated 21022018- clean.docx (Protocol)
Attachments [3] 2533 2533 0 0
/AnzctrAttachments/374279-2018.008 RMH PICF V2.0 dated 21022018 -clean .docx (Participant information/consent)

Contacts
Principal investigator
Name 80174 0
Dr Irene Ng
Address 80174 0
Royal Melbourne Hospital
300 Grattan St
Parkville
VIC 3052
Country 80174 0
Australia
Phone 80174 0
+61 03 93427540
Fax 80174 0
Email 80174 0
[email protected]
Contact person for public queries
Name 80175 0
Irene Ng
Address 80175 0
Royal Melbourne Hospital
300 Grattan St
Parkville
VIC 3052
Country 80175 0
Australia
Phone 80175 0
+61 03 93427540
Fax 80175 0
Email 80175 0
[email protected]
Contact person for scientific queries
Name 80176 0
Irene Ng
Address 80176 0
Royal Melbourne Hospital
300 Grattan St
Parkville
VIC 3052
Country 80176 0
Australia
Phone 80176 0
+61 03 93427540
Fax 80176 0
Email 80176 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
EmbaseWarm humidified CO2 insufflation improves pericardial integrity for cardiac surgery: a randomized control study.2022https://dx.doi.org/10.23736/S0021-9509.22.12004-5
N.B. These documents automatically identified may not have been verified by the study sponsor.