Title: Development of a patient-maintained sedation device to allow patients to safely control their own sedation levels during surgical and medical procedures.
Funder: Department of Health and Social Care

Abstract: 1. Project management Lead: Dr Bedforth This package will plan, monitor and control the strategic vision and daily administration of our work. Three-monthly management group meetings will review progress in all other packages. Deliverables: 1) Final project report and study review Milestones: 1) Management group meetings 2. Patient and public involvement Lead: Adrian Manhire and lay-person collaborator We will convene a patient advisory group (PAG). This group will receive updates on the project and contribute to all aspects of patient-maintained sedation device (PMSD) development and clinical study. The group will specifically contribute to work package 3 to ensure the PMSD design meets user needs, and to work package 4 for the methodology of our clinical study and review of materials. Deliverables: 1) Participation in widespread dissemination of results. Milestones: 1) Patient advisory group meetings with agendas outlined below 3. Device development: Graphical user interfaces (GUI) and hardware development Lead: Professor Breedon The aim of this work package is to design and develop the hardware and software for a CE-marked PMSD. User research to understand needs of patients and anaesthetists will be conducted with our PAG. We will develop an interface for communication between existing TCI algorithms and the patient handheld device. Working with the PAG we will also examine the ergonomic design of the handheld trigger as well as the patient-GUI, which will deliver feedback to patients. The clinician-GUI will allow pre-operative customisation and intra-operative monitoring of the sedation programme by the doctor. Usability and stability system testing will ensure suitability for patient trials based on IEC62366. We will address effectiveness, reliability, safety and regulatory requirements. We will apply risk management standards to the hardware and software design, development, testing and verification. Figure 1, attached to this application, shows our proposed device developments and the contribution BBraun will make to this work package. Deliverables: 1) Initial prototype for clinical effectiveness study 2) Advanced prototype complete for commercialisation Milestones: 1) Completion of hardware and GUI interfacing for initial prototype 2) Completion of advanced commercial prototype 4. Clinical Study Lead: Dr Hewson We will study patients undergoing orthopaedic surgery to evaluate the safety and effectiveness of our PMSD. Patients will be recruited pre-operatively and randomised to the PMSD or anaesthetist-controlled sedation. The purpose of the study will be to collect data demonstrating three outcome themes. Firstly; clinical aspects of patient-maintained sedation including depth of sedation and recovery time. Secondly; patient safety and avoidance of complications. Thirdly; patient satisfaction and control. From our pilot research and the existing scientific literature we hypothesise lower doses of sedation given in the PMSD-group will result in faster times to medical discharge from recovery, with fewer adverse events such as hypotension or reduction in blood oxygen saturation levels. Deliverables: 1) Report for submission to peer-reviewed journal Milestones: 1) Ethical & regulatory approval 2) Recruitment completed 3) Statistical analysis, report generation 5. Commercialisation and health economics Lead: Dr Harris Economics assessment will be conducted in collaboration with East Midlands RDS to determine the cost savings through faster patient recovery and avoidance of sedation-related complications. This will also give an indication as to device pricing in the market place. Commercialisation of the device will be through license agreement with BBraun. BBraun will assist with market analysis and product design with a view to distribution to market. Deliverables: 1) Marketing strategy plan and commercialisation report 2) Health economic report Milestones: 1) Pilot health economic assessment

Lay abstract: Many medical and surgical procedures are performed with patients awake rather than unconscious under a general anaesthetic. Many patients feel apprehensive about having their surgical or medical procedure awake, so doctors and nurses often give sedation medicine to reduce anxiety. Medical staff judge how much sedation to provide, but patients may receive more or less sedation than they want or need. This results in poor care. We want to enable patients to control their own level of sedation, so that they receive an appropriate amount of sedation and feel empowered by being able to do so. We intend to build and test a sedation device for patients to control using a simple handset. A handheld trigger will increase their sedation level, but if the patient wishes to be more awake, they can simply keep hold of the handset but not press the trigger. The device will have safety features including a 'lock-out' to prevent overdose and will only be used under the direct supervision of a specialist doctor (anaesthetist). Similar devices already exist for painkiller medicines. Our device will use an existing sedation medicine and machine, but adapt the way it is operated, to allow patient control. We will involve a patient advisory group to provide design advice in order to make the handset and device safe and user-friendly. This technology could benefit a huge number of patients attending hospital for operations or medical investigations such as bowel or heart examinations. The device will be patient-centred (as the patient will be in control) and should therefore improve overall experience. One of the key benefits to patients may be faster recovery from surgical and medical procedures and therefore earlier discharge from hospital. We aim to investigate our working prototype in patients undergoing bone and joint surgery under sedation.

Research activity codes: 5.3 MEDICAL DEVICES;6.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL