None listed
Conditions
Brief summary
Research Aims To assess the efficacy of warm humidified carbon dioxide (CO2) insufflation in reducing the time to return of bowel function in patients undergoing open colorectal surgery. Participants Adult participants undergoing open colorectal surgery at Dandenong Hospital who meet the inclusion and exclusion criteria. Methods Eligible participants will be randomised to receive standard of care or standard of care plus warm humidified carbon dioxide insufflation of the open wound during their scheduled open colorectal procedure. Insufflation will be provided with the HumiGard Surgical Humidification system, up to 10L of carbon dioxide gas will be slowly insufflated into the surgical cavity for the duration of the operation. Participants will be blinded to their allocation. Expected outcomes Completing this project will allow us to determine whether warmed and humidified carbon dioxide gas can assist with accelerating the recovery of bowel function postoperatively, potentially leading to shorter hospital stays and improved patient outcomes.
Interventions
HumiGard system.
The investigational device to be used will be the Fisher and Paykel HumiGard Surgical Humidification System. The HumiGard system is a heat delivery system that allows insufflation of warm humidified CO2 into the open wound cavity for the entire duration of the procedure, ranging from 2 to 4 hours. Dry medical CO2 is delivered at a flow rate of 10 litres per minute and a pressure of 4.5 bar from a medical pressurized gas cylinder via a 6.35 mm PVC tube to an open surgery humidif
HumiGard system. The investigational device to be used will be the Fisher and Paykel HumiGard Surgical Humidification System. The HumiGard system is a heat delivery system that allows insufflation of warm humidified CO2 into the open wound cavity for the entire duration of the procedure, ranging from 2 to 4 hours. Dry medical CO2 is delivered at a flow rate of 10 litres per minute and a pressure of 4.5 bar from a medical pressurized gas cylinder via a 6.35 mm PVC tube to an open surgery humidification system. It consists of a bacterial filter, and a humidification chamber filled with 180 ml sterile water, positioned on a humidifier controller that includes an integrated temperature and flow sensor The outlet of the humidification chamber is connected to a thermally insulated 2.5 m long heated insufflation tube that maintains temperature and humidity of the gas to its outlet. The humidified and warm CO2 enters a gas diffuser (VITAdiffuser, Cardia Innovation AB, Stockholm, Sweden) consisting of a 25 cm long PVC tube (inner diameter of 2.5mm) with polyurethane foam at its end. The cylindrical polyurethane foam tip diverts the gas jet into multiple directions via the many small paths inside the foam. The gas is thus uniformly distributed and the large diffuser surface area greatly reduces the velocity of the outflow. The Fisher and Paykel Healthcare Ltd HumiGard system will be set up as per user instructions in the theatre by the investigators. The device will be operated by the circulating nurse and the sterile portion placed in the wound by the consulting surgeon. The intervention will be closely assessed and monitored for adherence during the procedure will clear documentation on medical records. The anaesthetist will be made aware of the CO2 and may need to change ventilation to compensate for CO2 absorption. The study-related risk is considered to be extremely low, since the application of CO2 insufflation in open surgery is approved on the Australian Therapeutic Goods Register, and Medsafe WAND notified, and is used in clinical settings routinely outside the study.
Sponsors
Mr Asiri Arachchi, Department of Colorectal Surgery, Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing elective or emergency open colorectal resection 2. Able to give informed consent
Exclusion criteria
1. Pregnancy 2. Terminal organ impairment 3. Patients that have to return to theatre for pathology unrelated to return of bowel function such as revisions or re-look laparotomy washouts. 4. Evidence, preoperatively, of any of the following: sepsis, severe sepsis, or septic shock 5. Contraindication for CO2 6. BMI > 40 as patients with morbid obesity will have higher mortality 7. Current slow transit constipation 8. History of laparotomy within the last 60 days 9. Systemic steroid use or other immunosuppressant medication 10. ASA score greater than or equal to 4
Outcome results
None listed