Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

  • STATUS
    Recruiting
  • End date
    Jun 7, 2022
  • participants needed
    750
  • sponsor
    Australian and New Zealand Intensive Care Research Centre
Updated on 7 December 2020
Investigator
Janani Sivasuthan
Primary Contact
John Hunter Hospital (7.3 mi away) Contact
+50 other location

Summary

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.

Description

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.

Details
Treatment Early activity and mobilisation
Clinical Study IdentifierNCT03133377
SponsorAustralian and New Zealand Intensive Care Research Centre
Last Modified on7 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Critically Ill, Mechanically Ventilated?
Do you have any of these conditions: Do you have Critically Ill, Mechanically Ventilated??
Do you have any of these conditions: Do you have Critically Ill, Mechanically Ventilated??
Aged 18 years or older
Intubated and expected to remain invasively mechanically ventilated the day after tomorrow
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
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

Dependent for activities of daily living in the month prior to current ICU admission (gait aids are acceptable)
Documented cognitive impairment
Proven or suspected acute primary brain pathology (e.g. traumatic brain injury, stroke, hypoxic brain injury)
Proven or suspected spinal cord injury or other neuromuscular disease that will result in permanent or prolonged weakness (not including ICU acquired weakness)
Has rest in bed orders and/or has bilateral non-weight bearing orders for the lower limbs
Life expectancy less than 180 days due to a chronic or underlying medical condition
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
Unable to communicate in the official local language
This is not the first ICU admission in the index hospital admission
Fulfilled all inclusion criteria and none of the exclusion criteria 72 hours
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