Participant Information
What is the purpose of the study?
Optimising sedation for patients undergoing mechanical ventilation is a key aspect of ICU care. Commonly used sedative medications are associated with significant adverse side effects that impact on patient experiences and outcomes.
Ketamine represents a novel sedative option in ICU, however further research into its use is needed. Before we conduct a large-scale randomised controlled trial (RCT) of ketamine sedation, we need to explore current sedation practices, as well as investigate staff attitudes, views, and experiences that could potentially influence sedative choice on ICU. This will help predict barriers to implementation (organisational, cultural, or practical) and will allow us to plan accordingly when designing any subsequent RCTs.
Why have I been chosen?
You have been invited to take part as you are a member of the medical or nursing team with experience caring for patients receiving sedation on ICU and I am interested in hearing your views on these topics.
Do I have to take part?
No, participation is entirely voluntary. If you do decide to take part you will be asked to confirm your consent below.
Responses are anonymous and will not be recorded until you complete the questionnaire. You may withdraw at any point until you have submitted your responses, at this point responses will have been anonymised and therefore we will be unable to identify your rersponses for withdrawal.
What will happen to me if I take part?
If you agree the participate then all we require is for you to complete a short (15-20minute) survey on sedation practices where you work.
These responses will be recorded anonymously and therefore we ask that all responses be kept free of any potentially identifiable information. Common answers, ideas, thoughts, and themes across the questionnaires will be highlighted and analysed, and will provide representative samples from different regions.
The questions focus around the following key areas:
- Current practices with regards to sedation to facilitate mechanical ventilation in your unit (including commonly prescribed sedatives, protocols, and variation)
- Your clinical experiences with sedated patients / the use of sedative medications.
- Factors influencing your decision making with regards to sedation.
- Your experiences / concerns / expectations around the use of ketamine in ICU.
- Your potential willingness to be involved in a subsequent larger RCT.
Can I withdraw from the study?
Yes, you can withdraw from the study at any point from agreeing to participate up until you submit your final responses, at this point responses will have been anonymised and therefore we will be unable to identify your rersponses for withdrawal.
Who is organising/ funding the study?
This study is being run by researchers from the University of Leeds. This research activity forms part of a PhD in Medical Research at the University of Leeds (Leeds Institute of Medical Research).
The lead supervisor is Professor Simon Howell (Associate Professor and Honorary Consultant Anaesthetist, Leeds Institute of Medical Research) – s.howell@leeds.ac.uk
Who has reviewed the study?
Approvals have been sought from the School of Medicine Research Ethics Committee (SoMREC/SHREC project number MREC 22-004) and the Health Research Authority (HRA) IRAS 322789
Use, dissemination and storage of research and personal data
During this questionnaire we do not need to collect any personal or identifiable information and ask that you refrain from including any potentially identifying information in your answers. Any information will not be shared beyond the immediate research team and will be kept safe and secure, following all data protection and privacy rules.
As this survey is anonymous, once you submit your responses you will not be able to withdraw them.
All data stored beyond the end of the study will be anonymous and no identifiable information will be published in the results
All research staff involved with this study will comply with the requirements of the appropriate data protection legislation (including the General Data Protection Regulation and Data Protection Act) with regard to the collection, storage, processing and disclosure of personal information and will uphold the Act’s core principles.
Where can you find out more about how your information is used?
For further information about the University’s use of personal data, please see:
https://dataprotection.leeds.ac.uk/wp-content/uploads/sites/48/2019/02/Research-Privacy-Notice.pdf or contact the University of Leeds Data Protection Officer dpo@leeds.ac.uk.
You can also find more information on the Health Research Authority website: www.hra.nhs.uk/information-about-patients or through contacting the research team through the contact details provided below.
What will happen to the results of the study?
Results of the study will form part of a PhD thesis to be submitted to the University of Leeds.
Results and write-ups may be shared within the University of Leeds or submitted to peer-reviewed journals and scientific conferences for dissemination to the wider research community, copies of which may be available upon request. Whilst direct quotations may be used, all write-ups will remain strictly anonymous.
Contact for further information
If you would like to speak with a member of the research team then please contact the principal researcher:
Dr Nicholas Richards – n.d.richards1@leeds.ac.uk
Or lead supervisor: Professor Simon Howell – s.howell@leeds.ac.uk
MREC 22-004 / IRAS 322789