None listed
Conditions
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.
Interventions
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 re
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.
Sponsors
Fisher and Paykel Healthcare pty ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed