Treatment of invasively ventilated adults with Early Activity and Mobilisation
A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared with Standard Care in Invasively Ventilated Patients in Intensive Care
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 eleven years we have developed and tested a multidisciplinary intervention called “early activity and mobilisation” to assess functional recovery and patient-centred outcomes in ICU survivors. As part of the TEAM program of research, we have: (1) published reviews and systematic reviews; (2) published multicentre observational study to define standard care; and, (3) published a pilot RCT to show feasibility of implementing TEAM ‘early activity and mobilisation’ protocol in Aus/NZ ICU settings. Results from the pilot RCT led to the successful NHMRC grant application for TEAM phase III RCT.
The TEAM phase III is a definitive, multicentre, randomised controlled trial of early activity and mobilisation compared to standard care. The trial will recruit patients who are adult, intubated and expected to remain invasively mechanically ventilated the day after enrolment and are physiologically stable. Recruiting 750 patients, this will be the largest trial ever conducted of early mobilisation in ICU. If the intervention is beneficial, the trial will establish a paradigm shift away from immobilisation that will transform Australian, and international, ICU clinical practice.
Aims: To evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome “days alive and out of hospital to day 180”. The effect of the intervention on mortality, health status, physical function, and cognitive function at day 180, as well as the cost-effectiveness of the intervention, will also be evaluated.
Primary outcome: 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).
Study Progress: Patient recruitment commenced in February 2018. Target 750 patients are recruited from Australia, New Zealand, Germany, Ireland and UK. Keep up to date with our progress and study updates on Twitter @TEAMtrialICU
Study data entry webpage: www.teamtrial.org.au
Endorsement and Registration: The study is endorsed by the ANZICS CTG and it is registered in ClinicalTrials.gov (NCT03133377) https://clinicaltrials.gov/ct2/show/NCT03133377
Co-enrolment: Co-enrolment in non-rehabilitation studies will be considered by the Management Committee as requested. Co-enrolment in any other rehabilitation study is not permitted.
1. Team Study Investigators, Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care 2015;19:81.
2. Hodgson CL, Bailey M, Bellomo R, Berney S, Buhr H, Denehy L, Gabbe B, Harrold M, Higgins A, Iwashyna TJ, Papworth R, Parke R, Patman S, Presneill J, Saxena M, Skinner E, Tipping C, Young P, Webb S, Trial of Early Activity Mobilization Study Investigators. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU. Crit Care Med 2016;44:1145-52.
3. Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc 2016;13:887-93.
4. Hodgson CL, Udy AA, Bailey M, Barrett J, Bellomo R, Bucknall T, Gabbe BJ, Higgins AM, Iwashyna TJ, Hunt-Smith J, Murray LJ, Myles PS, Ponsford J, Pilcher D, Walker C, Young M, Cooper DJ. The impact of disability in survivors of critical illness. Intensive Care Med 2017;43:992-1001.
5. Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med 2017;43:171-83.