What is this study about?
Patients who are admitted to the Intensive Care Unit (ICU) with a life-threatening illness often receive invasive mechanical ventilation. This involves a tube inserted into the patient's airway and attached to a ventilator (breathing machine) to assist with their breathing. However, patients receiving this treatment are typically confined to bed (immobilised) with no active exercise. This immobilisation contributes substantially to the development of muscle weakness and wasting (ICU-acquired weakness). In turn, these problems are associated with poor outcomes for patients including increased hospital length of stay, increased mortality after hospital discharge, and impaired long-term functional recovery.
It is now recognised that immobilisation during prolonged invasive mechanical ventilation can be avoided and is a potentially modifiable cause of ICU-acquired weakness. Over the last eight years a multidisciplinary intervention called “early activity and mobilisation” has been developed and tested. Early activity and mobilisation have been demonstrated to be safe and feasible, albeit not routinely part of standard patient care. The TEAM (Treatment of invasively ventilated adults with Early Activity and Mobilisation) study is a multicentre, randomised controlled trial in patients expected to require prolonged mechanical ventilation.
This international trial will determine whether early activity and mobilisation delivered during invasive mechanical ventilation increases the number of days’ patients spend alive and out of hospital in the 180 days after randomisation. The trial will recruit 750 patients, and be the largest trial ever conducted of early mobilisation in ICU. The trial will establish whether early activity and mobilisation should become standard care. If the intervention is beneficial the trial will establish a new approach to the management of critically ill patients in the ICU.
When is it taking place?
This international study will run between November 2017 and December 2021 and includes sites in Australia, New Zealand, Ireland, Germany and the UK.
Who is leading the study?
Prof Carol Hodgson, Deputy Director, Australian and New Zealand Intensive Care Research Centre, Melbourne, Australia
The Intensive Care National Audit & Research Centre are the UK sponsor organisation and coordinating centre.
The study has funding from the National Health and Medical Research Council (NHMRC).
Clinicaltrials.gov.au (Registration No: NCT03133377)