A multi-centre non-inferiority cluster trial comparing outcomes related to nitrous oxide delivery by portable cylinder and pipeline in all patients undergoing surgery under general anaesthesia: Nitrous Oxide management to Balance heaLthcare and Environmental needs (NOBLE)
Method of nitrous oxide delivery in patients requiring surgery under general anaesthetic.
The NOBLE trial will have two distinct phases each lasting 5 weeks. Hospitals will be randomised 1:1 either to a control phase (pipeline nitrous oxide supply) followed by an intervention phase (cylinder nitrous oxide supply), or to an intervention phase followed by a control phase. The total trial intervention period will last 10 weeks, with a further 30 days to complete the follow-up of the last included patient to undergo surgery. Hospitals will be allocated in randomised blocks of random length (4 or 6). The allocation list will be prepared by an independent statistician at BCTU, and uploaded to the randomisation module of the REDCap electronic data capture tools hosted at Birmingham University, to ensure allocation concealment when each hospital is randomised. Prior to randomisation, local investigators will ensure all necessary equipment has been procured and is ready for use and will plan the delivery of education and training to anaesthetists and relevant theatre staff.
All patients (adults and children) undergoing surgery under general anaesthesia in participating hospitals (regardless of exposure to nitrous oxide anaesthesia)
Patients who have opted out of anonymous data sharing Patients undergoing repeat surgery within 30 days after a procedure recorded in the NOBLE trial