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Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation (TEAM(III))

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ClinicalTrials.gov Identifier: NCT03133377
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
ANZICS Clinical Trials Group
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

Brief 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.


Condition or disease Intervention/treatment Phase
Critically Ill, Mechanically Ventilated Behavioral: Early activity and mobilisation Phase 3

Detailed 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 and the 180 day follow up will be conducted centrally.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared With Standard Care in Invasively Ventilated Patients in Intensive Care
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Early activity and Mobilisation intervention
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
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

No Intervention: Standard of care
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.



Primary Outcome Measures :
  1. Number of days alive and out of hospital [ Time Frame: between randomisation and 180 days ]
    Any days spent in rehabilitation or a nursing home counted as days in hospital


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: From date of randomisation up to180days. ]
  2. Time from randomisation until death [ Time Frame: From date of randomisation unitl date of death from all cause, censored at 180days ]
  3. Ventilator-free days [ Time Frame: From date of randomisation until day 28 ]
    patients who die prior to day 28 will be assigned zero ventilator-free days

  4. ICU-free days [ Time Frame: From date of randomisation until day 28 ]
    patients who die prior to day 28 will be assigned zero ICU-free days

  5. Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [ Time Frame: Assessed at 180days ]
  6. 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 ]
  7. Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) [ Time Frame: Assessed at 180days ]

Other Outcome Measures:
  1. Delirium free days [ Time Frame: From date of randomisation until day 28 ]
    Will be measured using CAM-ICU and RASS score

  2. Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) [ Time Frame: Assessed at 180days ]
  3. Psychological function measured using Hospital Anxiety and Depression scale (HADS) [ Time Frame: Assessed at 180days ]
  4. Psychological function measured using Impact of Event Scale - Revised (IES-R) [ Time Frame: Assessed at 180days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133377


Contacts
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Contact: Janani Sivasuthan +61 3 9903 0932 Janani.Sivasuthan@monash.edu
Contact: Lynne Murray +61 419 155 983 Lynnette.Murray@monash.edu

Locations
Show Show 29 study locations
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
National Health and Medical Research Council, Australia
ANZICS Clinical Trials Group
Investigators
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Study Chair: Carol Hodgson ANZIC-RC

Additional Information:
Publications:
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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT03133377    
Other Study ID Numbers: TEAM U1111-1195-3567
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Australian and New Zealand Intensive Care Research Centre:
Early activity and mobilization, rehabilitation, intensive care
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes