Extrait

Background and study aims Immobilisation causes the size and strength of the muscles to reduce quickly. Intensive Care Unit-Acquired Weakness is a common problem which is not well understood. A combination of wasting of muscle and inflammation affecting nerves and muscles can cause loss of function and reduced quality of life. This can have long-term consequences, lasting for years. Previous studies suggest that artificially stimulating muscle activity in intensive care patients may reduce these processes. This has never been tested amongst a group of patients who have all had major injuries. Previous research has mainly looked at stimulation of leg muscles with electricity. The use of magnetic stimulation has never been tested. We will find out if stimulation of the arms in patients who have been admitted to the ICU due to major injury will stimulate the arms (due to their importance in activities of daily living) and will find out about the role of magnetic stimulation as an alternative to electrical stimulation. This is an initial (small-scale) study. This means that the main aim of this study is to collect enough information to tell us how many patients would have to be studied to provide a definite answer about the possible benefits of stimulation. Who can participate? Patients who have severe injuries who are admitted to the critical care unit at the Queen Elizabeth Hospital, Birmingham, can participate in this study. What does the study involve? Participants will receive either active electrical, active magnetic or sham stimulation. This will be chosen at random, with an equal chance of receiving any given stimulation. The stimulation will be applied to their arms every day for ten days. Blood samples will be taken when the participant agrees to take part and before and after the stimulation on three occasions. Before the stimulations begin, muscles in the arms will be assessed with ultrasound and a small sample (called a biopsy) will be taken from the biceps muscle. These will be done again at the end of the ten-day stimulation period. At the end, electrodes will be attached to the hands and arms in order to test the function of various nerves. These tests are known as nerve conduction studies. Tests of arm muscle strength will also be performed. When the participant is ready to leave the hospital, their ability to perform activities of daily living (feeding, dressing, walking, etc) will be assessed. Their quality of life will be measured at the time of discharge and six months later. What are the possible benefits and risks of participating? It is possible that participants who receive active stimulation might retain more strength in their muscles and be able to do more than patients who receive sham stimulation. Muscle biopsy carries slight risks (such as bleeding, discomfort or infection) and nerve conduction studies may be uncomfortable. Where is the study run from? The study is run from Queen Elizabeth Hospital, Birmingham, UK. When is study starting and how long is it expected to run for? The study is expected to start in late 2013. It is expected that patients will be recruited over a six-month period with follow-up continuing for a further six months after recruitment is completed. Who is funding the study? The study is funded by the NIHR Surgical Reconstruction & Microbiology Research Centre, UK. Who is the main contact? Mr Iain Smith [email protected]

Critère d'inclusion

• Disease: Intensive Care Unit-Acquired Weakness
• Domain: Critical Care

Liens

• ictrp
• isrctn