ANZICS CTG Endorsed Study
Treatment of invasively ventilated adults with early activity and mobilisation
Study Description
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. Weakness may be avoided with simple strategies of early exercise in ICU. 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 of early activity and mobilisation in patients expected to require prolonged mechanical ventilation. Recruiting 750 patients internationally, 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.
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/hospital discharge at day 28 and day 180; ICU-free days to day 28; ventilator-free days to day 28 and delirium free days to day 28; quality of life and physical function at day 180 measured using validated outcome questionnaires.
Management Committee
Carol Hodgson (Chair), Rinaldo Bellomo, Heidi Buhr, Belinda Gabbe, Meg Harrold, Alisa Higgins, Sally Hurford (PM – NZ), Theodore Iwashyna, Alistair Nichol, Jeffrey Presneill, Manoj Saxena, Stefan Schaller, Janani Sivasuthan (PM – overall), Lizzie Skinner, Claire Tipping, Steve Webb, Nia Wyn Davies and Paul Young.
Administering Institution
ANZIC Research Centre, Monash University
Collaborators
Medical Research Institute of New Zealand (MRINZ)
Intensive Care National Audit & Research Centre (ICNARC)
Sample Size
750 patients
Funding
NHMRC Project Grant $1,467,137.40
HRC Grant (NZ) NZ$1,011,247.00
Project Status as of June 2019
Current recruitment = 199 patients (as of Jun 30th 2019)
Number of active sites = 25 (Australia = 18, New Zealand = 5, Germany = 2, and Ireland = 1)
Sites
Ethics/CTRA
Recruitment
Data management/Monitoring/DSMC
Reference
CTG1516-05
Contact
Carol Hodgson (mail)