Consent Form and Patient information leaflet
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1 Consent Form and Patient information leaflet Introduction Around 2.9 million general anaesthetics are conducted annually in the UK. When patients are anaesthetised (put to sleep) for an operation the anaesthetist inserts a tube or mask (airway device) into their breathing passage to enable adequate Oxygen supply. This is a vital step as otherwise there will be dire consequences due to Oxygen starvation. A vast majority of these are done easily. However life threatening emergencies can occur during an anaesthetic while managing a patient's airway and can result serious harm including death. Often this is an unanticipated situation. More details are available on our website. ( If during your anaesthetic there have been difficulties in managing your airway (Difficult Airway) it is vital that this life saving information is made available during your next operation. This information will help your anaesthetist to conduct your next anaesthetic safely. What is this project about? The idea behind this project is to ensure that critical information about any difficulty encountered during your anaesthetic is readily available to your anaesthetist (anywhere in the UK) if you were to have another operation. What do I get from this? This project will provide you with a card DAS Airway Alert Card which will contain vital information about the difficulty during your anaesthetic and how it was managed. Because of limitations of space we can put only small amount of information on the card. Therefore
2 we will be creating a national database where we can hold detailed information about this event so that it will be available 24/7 to help plan your future anaesthetic. What are the benefits of getting the Airway Alert Card? You can carry this card, which will be a plastic card (same size as a credit card) and show it your anaesthetist when you go for your next operation. This will instantly alert your anaesthetist about your previous anaesthetic and therefore help manage your next one safely. What should I do with this card? Please retain this card safely as this card contains your personal information and medical details. You can take it with you when you visit a hospital. This information will be useful to not only an anaesthetist but also other medical professionals. Some examples where this will be useful are When you have a surgery Any other medical procedure that involves an anaesthetic or sedation e.g. endoscopy, dental procedures, other invasive procedures like examination under anaesthetic, injections under sedation Any emergency admission to a hospital Trauma, accidents requiring hospital treatment etc., How will my information be used? Your personal details will be used to print and send you the alert card. The main use of the information about your anaesthetic is to provide a safe anaesthetic for your next operation or procedure. This information may also be used for research purposes in the future. However none of your personal details will be used for research.
3 Will the data be used for any other purpose? The clinical information held in the database can be potentially used for future research as it can shed light on what made the anaesthetic difficult. This will help us (anaesthetists) to develop techniques to manage patient s airway more effectively and in a safe manner. For research purposes only a completely anonymous version of the database will be used. None of your personal information except your age at the time of incident and sex will be used. What information will be available on the internet? Who can access it? Medical details about your anaesthetic and the difficulties encountered will be entered into this database. There won t be any personal details available online. Your NHS number will be stored in this database in an encrypted format. The card will have a unique access code which will be used to link your details to this anonymised database. Only doctors from the United Kingdom who are registered with General Medical Council (GMC) will be able to access your details. They will also need your permission (when you hand over this card) to access your record. In exceptional circumstance e.g. when you have lost the card or unable to give permission due to medical reasons the registered doctors will be allowed to view your details using your NHS number. Please be assured that we will take all steps possible to hold your details safely and securely. Will my personal details be available online? None of your personal details will be stored online. Your personal information will retained securely in an offline database in our office. This is needed to print and post you the DAS Airway Alert Card. We store it to enable us to keep track of the database and re issue the card incase it is accidentally lost. Do I have to pay for the service? NO DAS sponsors the cost of running these services.
4 What happens if I lose the card? If you accidentally lose your DAS Airway Alert Card you can report it to our office. We will issue you a new card. Your old card and the access code printed on it will become void so that it will be useless should it fall into wrong hands. Our contact details for reporting a lost card will be available on our website under the Patient information section. Where can I find more information? All information about the Airway Alert Card and Difficult Airway Database are available on our website under Patient Information section.
5 Consent Form 1 Affix Patient Label I have provided Mr/Mrs/Ms... with relevant details about the Airway Alert Card and National Difficult Airway Database. Benefits of participation include: 1. Receive an Airway Alert Card. 2. Enable critical clinical information to be available to clinicians through internet. 3. Provide anonymised clinical information for airway research. Name of Clinician Designation.. Signature... Date. In view of the explanation given to me and the patient information leaflet provided: I consent to share my personal and clinical details with Difficult Airway Society (DAS). I understand that my personal details will be used only to provide me with DAS Airway Alert Card. I understand and consent for my clinical details to be stored securely by DAS in the National Difficult Airway Database and made available to clinicians securely via the internet to help with my clinical care. I also understand and consent that my anonymised clinical information may be used for clinical research purposes in the future. Patient s signature. Date Print Name..
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