Extrait

Background and study aims Chronic obstructive pulmonary disease (COPD) is the name given to a collection of diseases which affect the lungs. It is characterised by breathlessness, cough and excess mucus production and is often caused by smoking. COPD is frequently complicated by episodes of sudden worsening of respiratory symptoms, termed ‘exacerbations’. Sometimes during an exacerbation waste gases rise to a dangerous level. In this setting additional breathing support may be required. This ‘assisted ventilation’can be in the form of a tube placed directly into the patient’s lungs or much more commonly in the form of a tight fitting facial mask. This technique is called non-invasive ventilation (NIV) and can be lifesaving. Determining which patients should receive NIV is a complex decision that requires an assessment of an individual’s chances of survival should NIV be provided. However even specialist clinicians are overly pessimistic about the results of NIV treatment, which may lead to patients being inappropriately denied treatment. A simple, reliable tool to accurately identify patients likely to benefit and enhance clinical decision making has tremendous potential to further increase appropriate use of NIV. The study team has developed a score (tool) to predict the chance of successful treatment if NIV is started. For this score to be used in day to day practice it needs to be tested to ensure it works as expected. Therefore data will be collected about the health of a group of patients who experience assisted ventilation over a year. The aim of this study is to assess whether this tool is able to predict the outcome of assisted ventilation. In a second part of the study, a group of patients that have previously received assisted ventilation will be followed up over one year and data about their quality of life and the impact of COPD on their day to day activities will be collected. This data will allow clinicians to better understand what a patient experiences after ventilation. From this information particular markers of poor quality of life may be identified. Who can participate? Adults aged 35 and over with COPD who smoke a pack of cigarettes a day for 10 years and need treatment with a breathing machine. What does the study involve? In the first part of the study, information about patient’s health is collected by their usual care team over the course of one year and stored in a database. The tool is then applied to the data in order to find out if it would have accurately predicted the outcome of the patient, had the tool been applied to the patient at the time that they received ventilation. In the second part of the study, at baseline (immediately prior to discharge) and then again after three, six and twelve months, patients complete a number of questionnaires about their state of health as well as simple physical test such as their oxygen levels and weight, in order to assess their quality of life, the impact of COPD on their lives and whether they would wish to have ventilation again in the future should the need arise. What are the possible benefits and risks of participating? There are no direct benefits or risks to participants taking part in this study. Where is the study run from? 1. North Tyneside General Hospital (UK) 2. Guy's Hospital, London (UK) 3. St Thomas' Hospital, London (UK) 4. Queen's Medical Centre, Nottingham (UK) 5. St James's University Hospital, Leeds (UK) When is the study starting and how long is it expected to run for? May 2015 to February 2019 Who is funding the study? 1. Philips Respironics (UK) 2. Pfizer OpenAir (UK) Who is the main contact? 1. Ms Victoria Ferguson (public) 2. Dr Tom Hartley (scientific)

Critère d'inclusion

• Chronic Obstructive Pulmonary Disease (COPD)

Liens

• ictrp
• isrctn