TEAM TrialTEAM ICU logo2

A prospective multi-centre phase III randomised controlled Trial of Early Activity and Mobilisation compared with standard care in invasively ventilated patients in intensive care

Background

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.

Primary Objective

To assess if early activity and mobilisation of patients with prolonged IMV increases days alive and out of hospital at 180 days post-randomisation.

Patient Cohort

ICU patients who are invasively mechanically ventilated for >24 hours and considered stable, as determined by a number of physiological criteria, to mobilise.

Study Design

The study will recruit 750 patients across 35 sites worldwide. Patients will be randomised to standard care or early activity and mobilisation (the intervention).

Inclusion Criteria:

  1. Aged 18 years or older

  2. Expected to remain intubated and invasively mechanically ventilated the day after tomorrow

  3. Sufficient cardiovascular stability to make mobilisation potentially possible, as indicated by:

    • the absence of current brady-arrhythmia requiring pharmacological support

    • a current ventricular rate ≤ 150 bpm

    • most recent lactate ≤ 4.0 mmol/L

    • 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

    • most recent cardiac index ≥ 2.0 L/min/m2 (where measured)

    • no current requirement for VA ECMO

  4. Sufficient respiratory stability to make mobilisation potentially possible, as indicated by:

    • current FiO2 ≤ 0.6

    • current PEEP ≤ 16 cm H20

    • an absence of current requirement for NO, prone ventilation, neuromuscular blockers, ventilation, prostacyclin, VV ECMO or HFOV

    • 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

Outcomes

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).

Key Secondary Outcomes

  1. All-cause mortality at day180

  2. Time from randomisation until death

  3. Ventilator-free days to day 28;

  4. ICU-free days to day 28;

  5. Quality of life and physical function at day180 measured using EQ5D-5L, WHODAS version 2.0 12 level, ADL and IADL

Exploratory Secondary Outcomes

  1. Delirium-free days to day 28 or ICU discharge.

    • Cognitive function and Psychological function at day 180 measured using MOCA-Blind, HADS and IES-R.

Trial Registration

ClinicalTrials.gov - NCT03133377

Trial Coordination

TEAM is coordinated by the Australian and New Zealand Intensive Care-Research Centre.

For more information contact Kathy Brickell, Lead ICU Research Coordinator: This email address is being protected from spambots. You need JavaScript enabled to view it.