ANZICS CTG Endorsed Study

TEAM

Treatment of invasively ventilated adults with early activity and mobilisation

Study Description

TEAM is a program of research to evaluate the effect of early mobilisation to assess functional recovery and patient-centred outcomes of ICU survivors.

Rationale: Patients in intensive care (ICU) traditionally receive bed rest as part of the management of their critical illness. It is possible that patients develop muscle weakness even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital and delay functional recovery resulting in slower return home and to work. Moreover, it is plausible that failure of recovery of physical performance is a contributing factor to late mortality after critical illness. Weakness may be avoided with simple strategies of early exercise in ICU.

Goal: This program of research has included (1) reviews and systematic reviews of early mobilisation in ICU, (2) a multi-centre observational study to define standard care funded by the Intensive Care Foundation and endorsed by the ANZICS Clinical Trials Group, (3) a pilot RCT to determine if a phase III RCT of early mobilisation was feasible in ICUs in Australia and New Zealand. Results were published in 2016 (Crit Care Med) and we successfully received NHMRC funds to conduct a Phase III trial in 2016.

Management Committee

Carol Hodgson (Chair), Rinaldo Bellomo, Heidi Buhr, Belinda Gabbe, Meg Harrold, Alisa Higgins, Theodore Iwashyna, Jeffrey Presneill, Manoj Saxena, Janani Sivasuthan (Project Manager), 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

Sample Size

750 patients

Funding

NHMRC Project Grant $1,467,137.40

Project Status as of June 2018

The TEAM study was submitted to Alfred Ethics Committee in May 2017 under the National Mutual Acceptance Scheme and it will cover VIC, NSW, QLD and SA sites.

Expression of interest form was circulated to all the sites under ANZICS CTG and thus far 31 sites from Australia and New Zealand have expressed interest in the study. Site survey has been sent out to all 31 sites.

Research Path has been chosen to provide database services and the contract has been signed. A project kick-off meeting was held in May 2017. CRFs for the study are nearing final stages of TEAM Management Committee approval before commencing eCRF development.

TEAM DSMC members have been chosen and the DSMC charter has been finalised.

TEAM project manager, Janani Sivasuthan, was appointed in March 2017.

Reference

CTG1516-05

Contact

Carol Hodgson (mail)