The aim of this study is 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, physical, cognitive and psychological function at 180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The study will also explore process of care measures and baseline physiology and ICU mobility outcomes. The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.
The TEAM Trial is a definitive phase III multi-centre randomised controlled trial in mechanically ventilated patients. Supported by compelling preliminary data, the trial will determine whether early activity and mobilisation during mechanical ventilation improves days alive and at home at 6 months compared to standard care. Recruiting 750 patients, this will be the largest trial ever conducted of early mobilisation. Patients allocated to the early activity and mobilisation protocol (intervention group) will be assessed by a physiotherapist daily during the ICU stay to determine the highest level of mobility. This will determine the dosage and type of exercise that will be delivered, led by the physiotherapist with assistance from the multidisciplinary team. For both groups, concomitant care will be guided by the treating clinician. In addition, all post-ICU patient management will be at the discretion of the patient's ward-based treating physicians. Patients will be randomized via web-based system and de-identified data will be collected on the following: baseline demographics; comorbidities; sedatives, analgesics, corticosteroids and neuromuscular blockers; pain/sedation/delirium scores; tracheostomy, intubation and renal replacement therapy. The intervention will be administered during the ICU stay upto 28days and the Day 180 follow up will be conducted centrally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
750
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St George Hospital
Sydney, New South Wales, Australia
John Hunter Hospital
Sydney, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Number of days alive and out of hospital
Any days spent in rehabilitation or a nursing home counted as days in hospital
Time frame: between randomisation and 180 days
All-cause mortality
Time frame: From date of randomisation up to180days.
Time from randomisation until death
Time frame: From date of randomisation unitl date of death from all cause, censored at 180days
Ventilator-free days
patients who die prior to day 28 will be assigned zero ventilator-free days
Time frame: From date of randomisation until day 28
ICU-free days
patients who die prior to day 28 will be assigned zero ICU-free days
Time frame: From date of randomisation until day 28
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Time frame: Assessed at 180days
Independent activities of daily living measured with Barthel Activities of Daily Living (ADL) Index and The Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: Assessed at 180days
Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS)
Time frame: Assessed at 180days
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Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Mater Health
Brisbane, Queensland, Australia
Mater Private Hospital
Brisbane, Queensland, Australia
Caboolture Hospital
Caboolture, Queensland, Australia
The Prince Charles Hospital
Chermside West, Queensland, Australia
...and 39 more locations