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Search / Trial NCT03133377

Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Apr 25, 2017

Trial Information

Current as of May 20, 2025

Completed

Keywords

Early Activity And Mobilization, Rehabilitation, Intensive Care

ClinConnect Summary

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 highes...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Aged 18 years or older.
  • 2. Intubated and expected to remain invasively mechanically ventilated the day after tomorrow.
  • 3. Sufficient cardiovascular stability to make mobilisation potentially possible, as indicated by:
  • 1. the absence of current brady-arrhythmia requiring pharmacological support
  • 2. a current ventricular rate ≤ 150 bpm
  • 3. most recent lactate ≤ 4.0 mmol/L
  • 4. current combined noradrenaline/adrenaline infusion rate of ≤ 0.2 mcg/kg/min, OR if noradrenaline/adrenaline infusion rate has increased by more than 25% in the last 6 hours, dose must be \<0.1 mcg/kg/min.
  • 5. most recent cardiac index ≥ 2.0 L/min/m2 (where measured)
  • 6. no current requirement for VA ECMO
  • 4. Sufficient respiratory stability to make mobilisation potentially possible, as indicated by:
  • 1. current FiO2 ≤ 0.6
  • 2. current PEEP ≤ 16 cm H20
  • 3. an absence of current requirement for NO, prone ventilation, neuromuscular blockers, ventilation, prostacyclin, VV ECMO or HFOV
  • 4. current RR ≤ 45 bpm
  • Exclusion Criteria:
  • 1. Dependent for activities of daily living in the month prior to current ICU admission (gait aids are acceptable).
  • 2. Documented cognitive impairment.
  • 3. Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury).
  • 4. Proven or suspected spinal cord injury or other neuromuscular disease that will result in permanent or prolonged weakness (not including ICU acquired weakness).
  • 5. Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs.
  • 6. Life expectancy less than 180 days due to a chronic or underlying medical condition.
  • 7. Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision maker are not committed to full active treatment.
  • 8. Unable to communicate in the official local language.
  • 9. This is not the first ICU admission in the index hospital admission.
  • 10. Fulfilled all inclusion criteria and none of the exclusion criteria ≥ 72 hours

About Australian And New Zealand Intensive Care Research Centre

The Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) is a leading research organization dedicated to improving outcomes in critically ill patients through innovative clinical trials and research initiatives. Based at Monash University, the Centre fosters collaborative partnerships among clinicians, researchers, and institutions across Australia and New Zealand. Its focus on evidence-based practice and translational research aims to enhance the quality of intensive care, drive advancements in treatment protocols, and ultimately improve patient care in the intensive care unit (ICU) setting. ANZIC-RC is committed to addressing key challenges in critical care medicine, ensuring that findings from its trials contribute to better health outcomes and inform clinical guidelines globally.

Locations

London, , United Kingdom

Adelaide, South Australia, Australia

Leipzig, , Germany

Camperdown, New South Wales, Australia

Woolloongabba, Queensland, Australia

Nedlands, Western Australia, Australia

Sydney, New South Wales, Australia

Wollongong, New South Wales, Australia

Hamilton, , New Zealand

Brisbane, Queensland, Australia

Melbourne, Victoria, Australia

Perth, Western Australia, Australia

Launceston, Tasmania, Australia

Tauranga, , New Zealand

Wellington, , New Zealand

Bristol, , United Kingdom

Nottingham, , United Kingdom

Toowoomba, Queensland, Australia

Reading, , United Kingdom

Truro, , United Kingdom

Sydney, New South Wales, Australia

Swansea, , United Kingdom

Dublin, , Ireland

Prahran, Victoria, Australia

Melbourne, , Australia

Melbourne, Victoria, Australia

Dublin, , Ireland

Frimley, , United Kingdom

Auckland, , New Zealand

Auckland, , New Zealand

Redcliffe, Queensland, Australia

Lewisham, , United Kingdom

Perth, Western Australia, Australia

Subiaco, Western Australia, Australia

Sydney, New South Wales, Australia

Birtinya, Queensland, Australia

Brisbane, Queensland, Australia

Caboolture, Queensland, Australia

Chermside West, Queensland, Australia

Rockhampton, Queensland, Australia

Geelong, Victoria, Australia

Melbourne, Victoria, Australia

Melbourne, Victoria, Australia

Melbourne, Victoria, Australia

Berlin, , Germany

Munich, , Germany

Galway, , Ireland

Tallaght, , Ireland

Woolwich, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Carol Hodgson, Prof

Study Chair

ANZIC-RC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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