None listed
Conditions
Brief summary
This study aims to test a new automated device that delivers antibiotics gradually before surgery. The device, called IRIS, gives multiple smaller doses over 30 minutes, rather than one large dose, to reduce the risk of severe allergic reactions. We hypothesize that IRIS will both lower the chance of serious allergic events and still ensure patients receive enough antibiotic protection before surgery starts. By checking how easy IRIS is to use and whether it can safely administer the entire dose on time, we hope to show it can improve patient safety. If successful, this approach could make pre-operative antibiotic administration safer and more reliable in the future.
Interventions
Administration of antibiotics using a novel syringe that delivers the drug using a nonlinear infusion protocol. An automated syringe pump will be used to deliver the intervention. The syringe is loaded by the anaesthetist and connected to the patient’s IV line. The infusion rate and total volume are controlled by the automated infusion function, under the direct supervision of the anaesthetist.
A computer-controlled, nonlinear infusion algorithm will be employed, which modulates the infusion rat
Administration of antibiotics using a novel syringe that delivers the drug using a nonlinear infusion protocol. An automated syringe pump will be used to deliver the intervention. The syringe is loaded by the anaesthetist and connected to the patient’s IV line. The infusion rate and total volume are controlled by the automated infusion function, under the direct supervision of the anaesthetist. A computer-controlled, nonlinear infusion algorithm will be employed, which modulates the infusion rate based on a preset program. This protocol involves stepped rates rather than a single constant infusion. For participants, it means the infusion rate will increase over the period of the infusion so that the rate of infusion is low when the current cumulative dose is low. The infusion is started approximately 10 minutes after general anaesthesia has been confirmed and completes 30 minutes later. Cephazolin will be administered only. Compliance with the infusion protocol will be assessed through: Review of automated syringe pump logs (device analytics), case record form by clinician.
Sponsors
Sadleir Laboratories Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients having cardiac surgery and who require antibiotics.
Exclusion criteria
Non-elective procedure. Not able to provide informed consent.
Outcome results
None listed