ANZICS CTG Endorsed Study
Treatment of invasively ventilated adults with Early Activity and Mobilisation (TEAM)
Invasive mechanical ventilation (IMV) is a life-saving intervention, however patients receiving this intervention are typically confined to bed with no active exercise. This immobilisation contributes substantially to the development of muscle weakness and wasting, which are associated with increased hospital length of stay, increased mortality after hospital discharge, and poor long-term functional recovery. We now know that immobilisation during prolonged invasive mechanical ventilation can be avoided.
Over eight years we have developed and tested a multidisciplinary intervention called “early activity and mobilisation”. The TEAM trial is a definitive, multicentre, randomised controlled phase III study in patients expected to require prolonged mechanical ventilation. This 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. Recruiting 750 patients, this will 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 paradigm shift away from immobilisation that will transform Australian, and international, ICU clinical practice.
The primary outcome will be the number of days alive and out of hospital between randomisation and day 180 (with any days spent in rehabilitation or a nursing home counted as days in hospital). Secondary outcomes include all-cause mortality at ICU discharge, hospital discharge, day 28 and day 180; ICU-free days to day 28; ventilator-free days and delirium free days to day 28; quality of life and physical function at day 180 measured using EQ5D-5L, WHODAS 2.0, and ADL/IADL; cognitive and psychological function at day 180 measured using MOCA-Blind, HADS and IES-R.
The primary and secondary outcomes provide a comprehensive assessment of survival, health care utilisation, health status and functional recovery. They are selected for comparability with ongoing international trials to maximise the international relevance of this study.
Prof Carol Hodgson, Prof Rinaldo Bellomo, Ms Kathy Brickell, Ms Tessa Broadley, Prof Belinda Gabbe, Dr Doug Gould, Dr Meg Harrold, Dr Alisa Higgins, Prof Theodore Iwashyna, Prof Alistair Nichol, Prof Jeffrey Presneill, Dr Stefan Schaller, Dr Ary Serpa Neto, Ms Janani Sivasuthan, Dr Claire Tipping, Prof Steve Webb, Dr Paul Young, Ms Heidi Buhr
NHMRC, HRC Grant (NZ)
Carol Hodgson (email)