Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared With Standard Care in Invasively Ventilated Patients in Intensive Care

Conditions
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Critically Ill, Mechanically Ventilated

Intervention / Treatment
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* Behavioral: Early activity and mobilisation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early activity and Mobilisation intervention<br>Patients will be assessed daily by an ICU physiotherapist using the ICU Mobility Scale (IMS) to determine the dosage and type of active exercises the patient will receive, using the early activity and mobilisation protocol. This protocol is hierarchical, with the objective of each intervention session beginning with the highest level of activity possible for the longest time possible, which then steps down to lower levels of activity if the patient fatigues. The intervention will be administered on all days in which the patient is admitted to ICU during the index hospitalisation, censored at 28days after. | Behavioral: Early activity and mobilisation<br>* The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities<br>|
| No Intervention: Standard of care<br>The control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days alive and out of hospital | Any days spent in rehabilitation or a nursing home counted as days in hospital | between randomisation and 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | From date of randomisation up to180days. | 
| Time from randomisation until death |  | 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 | From date of randomisation until day 28 | 
| ICU-free days | patients who die prior to day 28 will be assigned zero ICU-free days | 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) |  | 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) |  | Assessed at 180days | 
| Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) |  | Assessed at 180days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early activity and mobilization, rehabilitation, intensive care