NOBLE
Research type
Research Study
Full title
A multi-centre non-inferiority cluster trial comparing nitrous oxide delivery by portable cylinder and pipeline
IRAS ID
347203
Contact name
Rupert Pearse
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
What is the rationale behind our study?
The NOBLE trial is studying the effects on patient outcomes of changes made to reduce the environmental impact of NHS Trust operating theatres. Specifically, the storage and supply of an anaesthetic gas called nitrous oxide (also known as laughing gas), which can be provided by pipeline with an outlet in the operating theatre, or by portable cylinders which are manually transported to the operating theatre. The pipeline system is known to be very wasteful, and nitrous oxide is a greenhouse gas.
What do we want to achieve?
We expect to show that cylinders are a less wasteful system of storage and supply, but have no harmful effect on patients. However, we don’t know for certain what we will find and having data which prove this could be very important worldwide as other countries have yet to consider this change. Alternatively, if there is any adverse effect for patients, it would clearly be very important to know this.
How will we achieve this?
Each hospital will collect data for two four-week periods; one where
patients are treated with pipeline nitrous oxide, and the other in with
portable cylinder nitrous oxide. Hospitals will configure their operating
theatres to one supply/delivery method or the other. We will decide at
random (like the toss of a coin) which hospitals will have pipeline nitrous oxide for the first four-week period and then cross over to cylinder, and which will do this the other way round. We will measure how quickly patients recover and go home in two groups in each hospital. We will also collect data on the other drugs used during anaesthesia, and whether there are any serious complications of anaesthesia or surgery.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0268
Date of REC Opinion
20 Feb 2025
REC opinion
Further Information Favourable Opinion