ANZICS CTG Endorsed Study

TEAM

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

  • Expected to activate 35 sites in total, including 2 additional sites in Germany and 2 in Ireland.
  • Collaborating through ICNARC to actively start-up and manage UK sites. EOI received from over 20 UK sites. The study has been endorsed by NIHR National Speciality Group and UK Critical Care Research Group and will be listed on the NIHR Portfolio. King’s College Hospital, UK lead site, has submitted the study for REC/HRA approval.
  • Has commenced initial work with one site in Brazil; protocol translation into Portuguese is underway. Additional sites in Brasilia have sent in EOI.

Ethics/CTRA

  • Under NMA, study approval granted by Alfred Ethics Committee in July 2017, covering sites in VIC, NSW, SA, QLD and WA. Awaiting on Tasmanian ethics approval.
  • NZ ethics approval granted in Sept 2017.

Recruitment

  • Current recruitment rate is above the expected rate. With the expected activation of additional sites, expect to maintain the rate required.

Data management/Monitoring/DSMC

  • eCRF database, provided by Research Path, supporting the sites efficiently.
  • Initial monitoring visits to sites has commenced.
  • Regular TEAM DSMC meeting was held in Jan 2019; reviewed safety report and given full support to proceed.

Reference

CTG1516-05

Contact

Carol Hodgson (mail)