Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001613291
Ethics application status
Approved
Date submitted
5/07/2018
Date registered
28/09/2018
Date last updated
31/10/2022
Date data sharing statement initially provided
30/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of warm humidified carbon dioxide insufflation on de-airing in patients undergoing aortic valve replacement or repair and/or mitral valve replacement or repair
Scientific title
Effect of warm humidified carbon dioxide insufflation on de-airing during aortic valve replacement or repair and/or mitral valve replacement or repair. A randomized controlled trial
Secondary ID [1] 295439 0
none
Universal Trial Number (UTN)
U1111-1210-4687
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac de-airing following cardio-pulmonary bypass 308697 0
Condition category
Condition code
Cardiovascular 307634 307634 0 0
Coronary heart disease
Surgery 307704 307704 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a blinded randomized controlled, prospective trial in patients undergoing aortic or mitral valve replacement or repair requiring cardiopulmonary bypass. Subjects will be randomly allocated to one of three groups.
• Group 1: Dry CO2 insufflation (Bone dry, 21 degrees Celsius)
• Group 2: Warm humidified CO2 insufflation (37 degrees celsius, 98% relative humidity)
• Group 3: Ambient air
For the duration of the surgery patients in the dry CO2 insufflation group will have bone dry room temperature CO2 insufflated into their thorax, similarly the warm humidified CO2 group will have humidified normothermic CO2 insufflated into their thorax, and the ambient air group will not be insuflated and left open to ambient room air.
Participants, surgeon, anaesthetist will be blinded to their allocation. The perfusionist will remain un-blinded and be responsible for delivering CO2 and turning the HumiGard™ system on or off depending on what group the patient is allocated to.
HumiGard™ system:
• F&P HumiGard™ MR870AEU surgical humidifier
• F&P HumiGard™ ST320 Surgical Humidification Kit
• ST300DF VITA-diffuser® Cardia Innovation
• 900ST100 Adapter

The intervention is complete at end of surgery, the performance of the HumiGard machine has been validated as per FDA and MEDDEF requirements
Intervention code [1] 301751 0
Treatment: Surgery
Intervention code [2] 301752 0
Prevention
Intervention code [3] 301822 0
Treatment: Other
Comparator / control treatment
The control group is group 3 : ambient air. this group will not recieve CO2 insufflation
Control group
Active

Outcomes
Primary outcome [1] 306621 0
number of bubbles on Transesophageal echocardiogram during the deairing period, from release of cross clamp until the end of deairing.
Timepoint [1] 306621 0
The deairing period, from release of cross clamp until the end of deairing.
Secondary outcome [1] 349040 0
Volume of microemboli .
Timepoint [1] 349040 0
Transesophageal echocardiogram score will be performed at the start of T0 (release of the aortic cross clamp), T4 (start of cardiac ejection), and T8 (end of deairing).
Secondary outcome [2] 349267 0
De-airing time before cardiac ejection (minutes) starting at removal of aortic cross clamp and ending at beginning of cardiac ejection. Time recorded to be judged by blinded anaesthetist.
Timepoint [2] 349267 0
before cardiac ejection (minutes) starting at removal of aortic cross clamp and ending at beginning of cardiac ejection
Secondary outcome [3] 349268 0
Serum cardiac troponin levels prior to surgery and the day after surgery.
Timepoint [3] 349268 0
Levels of troponin in the blood will be assessed from blood taken prior to and the day after surgery.
Secondary outcome [4] 349269 0
Peri-operative core temperature as measured by nasoesophageal temperature probe.
Timepoint [4] 349269 0
in 15 min intervals during the peri-operative period including induction and recovery
Secondary outcome [5] 349270 0
Temperature on the heart as measured by intramuscular probe at 15 minute intervals.
Timepoint [5] 349270 0
when the heart becomes accessible till when it is no longer accessible in 15 min intervals
Secondary outcome [6] 403557 0
Temporary neurocognitive impairment as assessed by The Modified Rankin Scale (mRS)
Timepoint [6] 403557 0
mRS score before surgery, prior to discharge and at follow-up

Eligibility
Key inclusion criteria
1. Patients scheduled for aortic valve replacement or repair and/or a mitral valve replacement or repair, will be included in the study.
2. Able to give informed consent
3. Male or female, 18 - 85 years of age
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant diagnosed and documented chronic obstructive pulmonary disease/emphysema
2. Significant (>50%) carotid artery disease
3. Prior cardiac or pulmonary surgery
4. Thoracic trauma
5. At anaesthetist discretion on ability to compensate for CO2

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by
computer software (i.e. computerised sequence generation)
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 117 subjects to be enrolled to participate in the study n = 39 per treatment group.
Statistical rational
An unpublished audit on 77 patients performed by the investigation site found that when bubbles were scored on a 0-4 scale by a blinded anaesthetist subjects exposed to cold dry CO2 insufflation had an average score of 2.218 (SD = 1.392). Patients exposed to heated humidified CO2 insufflation had an average score of 1.307 (SD = 0.655). To detect the same order of magnitude in the actual number of microemboli with 80% power and 95% confidence 37 subjects per arm are required. Assuming a 5% drop out 39 patients per group will be recruited.
Analysis:
Continuous variables will be analysed using the independent samples t-test (reporting mean and standard deviation) and Mann Whitney U (reporting median and interquartile range) test for parametric and non-parametric data respectively. The Shapiro-Wilk test will be used to assess normality of data as well as assessment of the data histogram. A p-value of <0.05 will mean that the data are not normally distributed.
Multiple linear regression to adjust for covariate data including age, gender, type of operation, surgical technique (open/laparoscopic). Where data are not normally distributed for the primary outcome, continuous data will be log-transformed prior to regression analysis.
We will use SPSS version 24 to analyse all data and 2-sided p values of <0.05 will be deemed significant, and 95% confidence intervals presented where appropriate.
Categorical data will be analysed using the Chi-squared test or Fischer’s exact test where appropriate.
Due to the low risk of the intervention and relatively small sample size no interim analysis or statistical stopping rules are planned.




Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/09/2019
Actual
25/02/2020
Date of last participant enrolment
Anticipated
13/09/2022
Actual
21/04/2022
Date of last data collection
Anticipated
25/10/2022
Actual
4/06/2022
Sample size
Target
117
Accrual to date
Final
117
Recruitment outside Australia
Country [1] 10621 0
New Zealand
State/province [1] 10621 0
Hamilton

Funding & Sponsors
Funding source category [1] 300030 0
Hospital
Name [1] 300030 0
waikato hospital
Country [1] 300030 0
New Zealand
Funding source category [2] 300087 0
Commercial sector/Industry
Name [2] 300087 0
Fisher and Paykel Healthcare
Country [2] 300087 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki, Auckland 2013
New Zealand
Country
New Zealand
Secondary sponsor category [1] 300319 0
None
Name [1] 300319 0
Address [1] 300319 0
Country [1] 300319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300878 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 300878 0
Ethics committee country [1] 300878 0
New Zealand
Date submitted for ethics approval [1] 300878 0
21/05/2018
Approval date [1] 300878 0
24/09/2018
Ethics approval number [1] 300878 0
Ethics ref: 18/NTB/88
Ethics committee name [2] 300880 0
Waikato District Healthboard Ethics Committee
Ethics committee address [2] 300880 0
Ethics committee country [2] 300880 0
New Zealand
Date submitted for ethics approval [2] 300880 0
28/03/2018
Approval date [2] 300880 0
22/11/2018
Ethics approval number [2] 300880 0
RD018044

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85134 0
Prof Adam El Gamel
Address 85134 0
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 85134 0
New Zealand
Phone 85134 0
+64 7 839 8899 ext 96514
Fax 85134 0
Email 85134 0
[email protected]
Contact person for public queries
Name 85135 0
Adam El Gamel
Address 85135 0
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 85135 0
New Zealand
Phone 85135 0
+64 7 839 8899 ext 96514
Fax 85135 0
Email 85135 0
[email protected]
Contact person for scientific queries
Name 85136 0
Adam El Gamel
Address 85136 0
Waikato Hospital
Pembroke Street
Hamilton 3204
Country 85136 0
New Zealand
Phone 85136 0
+64 7 839 8899 ext 96514
Fax 85136 0
Email 85136 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
Patient information in private and will only be seen by the treatment team. Findings of this trial will be published as a data set.


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.