Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001264774
Ethics application status
Approved
Date submitted
13/09/2022
Date registered
23/09/2022
Date last updated
24/03/2024
Date data sharing statement initially provided
23/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to investigate warm and humidified carbon dioxide delivery to the surgical site in patients undergoing craniotomy.
Scientific title
A pilot study to investigate the safety and tolerability of warm and humidified carbon dioxide delivery to the surgical site in patients undergoing craniotomy.
Secondary ID [1] 307962 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial tissue desiccation 327621 0
Brain aneurysm 327636 0
Condition category
Condition code
Surgery 324710 324710 0 0
Other surgery
Neurological 324724 324724 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Warm and humidified carbon dioxide delivery for craniotomy
Participants in this study will be adults who have a brain aneurysm that requires clipping through a pterional craniotomy.
The Fisher and Paykel Healthcare surgical humidification system to be used in this study consists of a humidifier, tubing kit and patient interface.

The interface is placed (by the operating neurosurgeon) on the edge of the surgical site, along with the surgical drapes and towels. The operating surgeon is responsible for administering the delivery of the carbon dioxide to the surgical site.

The operating surgeon will receive a single 1 hour face-to-face training session which will be delivered by a Fisher and Paykel representative prior to the first use of the device.

The device delivers medical grade carbon dioxide that is warmed (approximately 37degrees Celsius) and humidified (greater than 95 percent relative humidity) to the open wound for the duration of the surgical procedure.

The warm, humidified carbon dioxide is in contact with exposed tissue and works to maintain normal body conditions and to reduce continuous drying from the surgical site.

Patients will be monitored for intervention related adverse events for 30 days post surgery.

It is not applicable to monitor adherence to the intervention as the surgical humidification system does not have the ability to collect or store usage data.
Intervention code [1] 324421 0
Treatment: Devices
Comparator / control treatment
The control group will undergo craniotomy with the surgical site exposed to the operating theatre. All other routine standard of care procedures and tests before, during and after the surgery remained unchanged.
Control group
Active

Outcomes
Primary outcome [1] 332531 0
The primary outcome of the study is the number of device related adverse events (AE) up to 30 days post-surgery. As the device is used during surgery and the patient is anesthetized, tolerability cannot be self-reported by the patient. Consequently, tolerability will be considered the absence of any severe device related AE during surgery and up to 30 days post-surgery. AEs will be collected from operating notes, medical records and self reported by the patient during in-patient and clinic visit post-surgery.

Severity and causality of the adverse events will be evaluated by the operating surgeon and independently by an independent reviewer who is an expert in the area of neurosurgery.

The possible adverse intervention related events include:
Adverse reaction to CO2
Systemic hyperthermia
Vasodilation and bleeding
Hypercapnia
Acidosis
Intracranial/cerebral haemorrhage
Infection; superficial, deep or organ space.
Timepoint [1] 332531 0
Assed once at 30 days post surgery
Secondary outcome [1] 413825 0
Tissue temperature of the dura, recorded with a thermal camera at 30min intervals throughout intracranial portion of the procedure.
Timepoint [1] 413825 0
Every 30 minutes for the duration of the intracranial portion of the procedure.
Secondary outcome [2] 413862 0
Tissue temperature of the brain, recorded with a thermal camera at 30min intervals throughout intracranial portion of the procedure.
Timepoint [2] 413862 0
Every 30 minutes for the duration of the intracranial portion of the procedure.

Eligibility
Key inclusion criteria
Patients aged between 18-80 years.

Undergoing elective craniotomy for an aneurysm clipping through a Pterional approach, performed by a participating surgeon.

Has had adequate time to consider their participation in the study and discuss it with family and friends, and have their questions answered by a member of the study team.

Understands the risks and benefits of the study, and able to provide written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous pterional craniotomy on the same side as the proposed procedure. i.e left or right-hand side.

Patients with a known sensitivity to carbon dioxide

Patients who are being treated for emergency or acute procedures.

Patients with aneurysms classified as giant (larger than 25mm in diameter). Larger aneurysms result in a greater risk to the patient and may result in a more complex operation. Due to the main outcome of this study being safety minimizing the risk / complexity associated with procedure alone is preferential.

Patients with active medical or psychiatric conditions or participation in another clinical trial which, in the opinion of the PI / operating surgeon, would compromise (or interfere with) their ability to participate in the study, or means that it would not be in their best interest to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment will be achieved using opaque envelopes opened by the research team at the time of surgery setup. All patients will be randomised only once.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted in a 1:1 allocation ratio using block randomisation with a block size of 6. The randomization list will be generated using an online tool (www.sealedenvelope.com) prior to the start of study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/03/2023
Actual
23/03/2023
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
30
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23154 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 38512 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 312229 0
Commercial sector/Industry
Name [1] 312229 0
Fisher and Paykel Healthcare ltd
Country [1] 312229 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare pty ltd
Address
19-31 King Street
Nunawading
Melbourne
VIC
3131
Country
Australia
Secondary sponsor category [1] 313764 0
None
Name [1] 313764 0
Address [1] 313764 0
Country [1] 313764 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311608 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 311608 0
Level 2
South West
300 Grattan Street
Parkville Victoria
3050
Ethics committee country [1] 311608 0
Australia
Date submitted for ethics approval [1] 311608 0
27/07/2022
Approval date [1] 311608 0
29/09/2022
Ethics approval number [1] 311608 0

Summary
Brief summary
Open craniotomies, including procedures for tumour resection, aneurysm clippings or Arteriovenous Malformations (AVM), require an open wound including the removal of a section of skull to access to the brain.
Standard practice is to leave the open wound exposed to the operating theatre environment for the duration of the surgery, which may be anywhere from two to eight hours. The air in the theatre is cold and dry (18-21 degrees celsius and 20-50 percent relative humidity) compared to the normal physiological conditions within the brain (37degrees celsius, 100 percent relative humidity).
The wound is also subjected to the light from the surgical microscope which is used continuously for several hours for the microsurgical portion of the procedure. This light is very powerful and has the potential to produce high temperatures concentrated in and around the surgical site. This leads to continuous evaporation from the wound resulting in drying and desiccation of the neural tissue, intracranial blood vessels and dura mater.
Current practice to manage tissue desiccation is to repeatedly irrigate the wound throughout the procedure. Each time irrigation is applied the surgeons view of the surgical site is obscured and excess irrigation must be removed via suction. The frequent irrigation - visual obstruction - suction cycle disrupts the surgeon’s workflow and cyclically interrupts the procedure.
Warmed and humidified carbon dioxide insufflation is a therapy designed to deliver warm (37 degrees celsius) saturated (greater than 95 percent relative humidity) carbon dioxide to the surgical wound during the procedure, to prevent evaporation and desiccation. The intent of this study is to evaluate the safety of this insufflation to the surgical site during the craniotomy procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121698 0
Dr Alexios Adamides
Address 121698 0
1F Royal Parade Royal Melbourne Hospital/Melbourne Private Hospital, Parkville VIC 3052,
Country 121698 0
Australia
Phone 121698 0
+61 39342 8219
Fax 121698 0
Email 121698 0
alexios.adamides@mh.org.au
Contact person for public queries
Name 121699 0
Dr Alexios Adamides
Address 121699 0
1F Royal Parade Royal Melbourne Hospital/Melbourne Private Hospital, Parkville VIC 3052,
Country 121699 0
Australia
Phone 121699 0
+61 39342 8219
Fax 121699 0
Email 121699 0
alexios.adamides@mh.org.au
Contact person for scientific queries
Name 121700 0
Dr Alexios Adamides
Address 121700 0
1F Royal Parade Royal Melbourne Hospital/Melbourne Private Hospital, Parkville VIC 3052,
Country 121700 0
Australia
Phone 121700 0
+61 39342 8219
Fax 121700 0
Email 121700 0
alexios.adamides@mh.org.au

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?

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.