Title: Development of a novel stretcher for emergency and critical care patients
Funder: Department of Health and Social Care

Abstract: We aim to develop a novel stretcher for emergency and critical care patient transfer which features include active warming, padding, X-ray transparency, foldability and a single-use cover. Current practice by ambulance crews involves transferring patients from the site of an accident on scoop stretchers or spinal boards which are hard and cold. This causes possible pressure sores, cross-infection, hypothermia with resultant poor patient outcomes, delays to ambulance crews and unnecessary additional costs to the NHS. The research aims to develop and demonstrate that the Enhanced Emergency Stretcher (EES), which the patient stays on throughout their pre- and in-hospital journey, is effective in increasing patient comfort, improving patient outcomes and thus reducing hospital stays. It should also increase efficiency of ambulance crews and therefore altogether provide cost savings to the NHS. The team will start by clearly identifying patient needs for a Product Design Specification which is used to make a small number of advance working prototypes for a formative usability study. In the study the EES prototypes will be safety tested in a laboratory environment and then by healthcare staff using mannequins. Feedback on all aspects of the study will go towards finalising the design for manufacture (DFM) and these final products will be usability tested by ambulance crews using healthy volunteers in a real-world environment. A technical file including the clinical evaluation report, design, regulatory testing and DFM details will be submitted to a notified body for approval in order to fulfil regulatory requirements for CE-marking. We expect to complete the development and usability studies within this 36-month project which will enable the team to begin marketing of the EES as a CE-marked class IIa medical device immediately after completion. We will not disseminate findings until patent protection on all innovative aspects of the EES have been filed.

Lay abstract: Ambulance crews attend over 19,000 emergencies each day in the UK. Most are by road ambulance, some are by air ambulance. Patients are usually transported from the site of illness or injury to an Emergency Department at an NHS hospital. Stiff metal or plastic boards are used to pick patients off the ground and then place them on the ambulance trolley. This equipment has not changed much over the last fifteen years. Common complaints from patients being transported using the metal or plastic boards include feeling cold and uncomfortable, especially where the body is lying on a hard surface with only a few points of contact. Patients are thus subject to increased pressure and pain. Mattresses are not used to cushion the scoops because they are heavy, difficult for ambulance and hospital staff to lift and are very difficult to clean. This project will result in the development of an entirely new concept in the handling of patients during ambulance transfers while still complementing the current aspects that are effective. The novel Enhanced Emergency Stretcher (EES) will be heated, lightweight, safe for transfers and will have a single-use disposable cover, so each patient has a clean, infection-free surface to lie on. The EES will be safe for use during X-rays and scans, so the patient does not need to be moved off the stretcher if an X-ray or scan is needed. It will have battery-powered heating to keep patients warm and reduce the possibility of hypothermia. Additionally, it will be padded to keep the patient comfortable and reduce the risk of pressure sores. All these features should improve outcomes for patients, reduce their stay in hospital and therefore save the NHS money. The lead applicant has completed a proof of concept study funded under the NIHR i4i Connect award to develop a prototype. The current application is to fund a full programme of development. Patients and the public have been involved at all stages of the i4i Connect project and this application itself was discussed at length at a recent Trauma PPI Group meeting in Birmingham. The Trauma PPI Group will meet regularly during the project to review developments. The project will start by clearly identifying patient needs, followed by the design and production of a small number of advanced working prototypes. These will be safety tested in a laboratory environment and then by clinical staff using mannequins rather than patients. When the design is finalised, a full usability test will be conducted by ambulance crews using healthy volunteers in a real-world environment. The final products will be fully-tested and meet the necessary regulatory approvals (CE-marking) so the EES can be ready to be manufactured for use across the NHS.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;5.3 MEDICAL DEVICES
Health categories: GENERIC HEALTH RELEVANCE