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

Primary Purpose

Critically Ill, Mechanically Ventilated

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Early activity and mobilisation
Sponsored by
Australian and New Zealand Intensive Care Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critically Ill, Mechanically Ventilated focused on measuring Early activity and mobilization, rehabilitation, intensive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Prince Alfred Hospital
  • St George Hospital
  • John Hunter Hospital
  • Royal North Shore Hospital
  • Wollongong Hospital
  • Sunshine Coast University Hospital
  • Mater Health
  • Mater Private Hospital
  • Caboolture Hospital
  • The Prince Charles Hospital
  • Redcliffe Hospital
  • Rockhampton Hospital
  • Toowoomba Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Launceston General Hospital
  • Geelong Hospital - Barwon Health
  • St Vincent's Hospital Melbourne
  • Austin Health
  • Cabrini Health
  • Epworth Richmond
  • Western Health
  • Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Fiona Stanley Hospital
  • Royal Perth Hospital
  • St John of God Hospital
  • Royal Melbourne Hospital
  • The Charité
  • Universitätsklinikum Leipzig
  • Klinikum rechts der Isar der Technischen Universität Mϋnchen
  • Beacon Hospital
  • St Vincent's Hospital
  • Galway Hospital
  • Tallaght Hospital
  • Auckland City Hospital (CVICU)
  • Auckland City Hospital (DCCM)
  • Waikato Hospital
  • Tauranga Hospital
  • Wellington Hospital
  • Bristol Royal Infirmary
  • Frimley Park Hospital
  • University Hospital Lewisham
  • King's College Hospital
  • Nottingham University Hospitals
  • Royal Berkshire Hospital
  • Morriston Hospital
  • Royal Cornwall Hospital
  • Queen Elizabeth Hospital Woolwich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early activity and Mobilisation intervention

Standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of days alive and out of hospital
Any days spent in rehabilitation or a nursing home counted as days in hospital

Secondary Outcome Measures

All-cause mortality
Time from randomisation until death
Ventilator-free days
patients who die prior to day 28 will be assigned zero ventilator-free days
ICU-free days
patients who die prior to day 28 will be assigned zero ICU-free days
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Independent activities of daily living measured with Barthel Activities of Daily Living (ADL) Index and The Lawton Instrumental Activities of Daily Living Scale (IADL)
Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS)

Full Information

First Posted
April 10, 2017
Last Updated
April 10, 2022
Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
National Health and Medical Research Council, Australia, ANZICS Clinical Trials Group, Medical Research Institute of New Zealand, Intensive Care National Audit & Research Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03133377
Brief Title
Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation
Acronym
TEAM(III)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
June 17, 2022 (Anticipated)
Study Completion Date
June 17, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
National Health and Medical Research Council, Australia, ANZICS Clinical Trials Group, Medical Research Institute of New Zealand, Intensive Care National Audit & Research Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 upto 28days and the Day 180 follow up will be conducted centrally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill, Mechanically Ventilated
Keywords
Early activity and mobilization, rehabilitation, intensive care

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
750 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early activity and Mobilisation intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early activity and mobilisation
Intervention Description
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
Primary Outcome Measure Information:
Title
Number of days alive and out of hospital
Description
Any days spent in rehabilitation or a nursing home counted as days in hospital
Time Frame
between randomisation and 180 days
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
From date of randomisation up to180days.
Title
Time from randomisation until death
Time Frame
From date of randomisation unitl date of death from all cause, censored at 180days
Title
Ventilator-free days
Description
patients who die prior to day 28 will be assigned zero ventilator-free days
Time Frame
From date of randomisation until day 28
Title
ICU-free days
Description
patients who die prior to day 28 will be assigned zero ICU-free days
Time Frame
From date of randomisation until day 28
Title
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Time Frame
Assessed at 180days
Title
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
Title
Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS)
Time Frame
Assessed at 180days
Other Pre-specified Outcome Measures:
Title
Delirium free days
Description
Will be measured using CAM-ICU and RASS score
Time Frame
From date of randomisation until day 28
Title
Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
Time Frame
Assessed at 180days
Title
Psychological function measured using Hospital Anxiety and Depression scale (HADS)
Time Frame
Assessed at 180days
Title
Psychological function measured using Impact of Event Scale - Revised (IES-R)
Time Frame
Assessed at 180 days
Title
All-cause mortality
Time Frame
From date of randomisation up to 28 days
Title
Days alive and out of hospital according to survival status
Description
Any days spent in rehabilitation or a nursing home counted as days in hospital.
Time Frame
From date of randomisation up to 180 days
Title
Days in hospital, rehabilitation facility or nursing home according to survival status
Description
According to D180 survival status
Time Frame
From date of randomisation up to 180 days
Title
Time from randomisation to ICU discharge
Time Frame
From date of randomisation up to 180 days
Title
Time from randomisation to hospital discharge
Time Frame
From date of randomisation up to 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Hodgson, Prof
Organizational Affiliation
ANZIC-RC
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
John Hunter Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
Country
Australia
Facility Name
Mater Health
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Mater Private Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Caboolture Hospital
City
Caboolture
State/Province
Queensland
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside West
State/Province
Queensland
Country
Australia
Facility Name
Redcliffe Hospital
City
Redcliffe
State/Province
Queensland
Country
Australia
Facility Name
Rockhampton Hospital
City
Rockhampton
State/Province
Queensland
Country
Australia
Facility Name
Toowoomba Hospital
City
Toowoomba
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Launceston General Hospital
City
Launceston
State/Province
Tasmania
Country
Australia
Facility Name
Geelong Hospital - Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
St Vincent's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Cabrini Health
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Epworth Richmond
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Western Health
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
St John of God Hospital
City
Subiaco
State/Province
Western Australia
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Melbourne
Country
Australia
Facility Name
The Charité
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität Mϋnchen
City
Munich
Country
Germany
Facility Name
Beacon Hospital
City
Dublin
Country
Ireland
Facility Name
St Vincent's Hospital
City
Dublin
Country
Ireland
Facility Name
Galway Hospital
City
Galway
Country
Ireland
Facility Name
Tallaght Hospital
City
Tallaght
Country
Ireland
Facility Name
Auckland City Hospital (CVICU)
City
Auckland
Country
New Zealand
Facility Name
Auckland City Hospital (DCCM)
City
Auckland
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand
Facility Name
Bristol Royal Infirmary
City
Bristol
Country
United Kingdom
Facility Name
Frimley Park Hospital
City
Frimley
Country
United Kingdom
Facility Name
University Hospital Lewisham
City
Lewisham
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Nottingham University Hospitals
City
Nottingham
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital Woolwich
City
Woolwich
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26968024
Citation
Hodgson CL, Bailey M, Bellomo R, Berney S, Buhr H, Denehy L, Gabbe B, Harrold M, Higgins A, Iwashyna TJ, Papworth R, Parke R, Patman S, Presneill J, Saxena M, Skinner E, Tipping C, Young P, Webb S; Trial of Early Activity and Mobilization Study Investigators. A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU. Crit Care Med. 2016 Jun;44(6):1145-52. doi: 10.1097/CCM.0000000000001643.
Results Reference
background
PubMed Identifier
27864615
Citation
Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18.
Results Reference
background
PubMed Identifier
27707476
Citation
Iwashyna TJ, Hodgson CL. Early mobilisation in ICU is far more than just exercise. Lancet. 2016 Oct 1;388(10052):1351-1352. doi: 10.1016/S0140-6736(16)31745-7. No abstract available.
Results Reference
background
PubMed Identifier
36286256
Citation
TEAM Study Investigators and the ANZICS Clinical Trials Group; Hodgson CL, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ. Early Active Mobilization during Mechanical Ventilation in the ICU. N Engl J Med. 2022 Nov 10;387(19):1747-1758. doi: 10.1056/NEJMoa2209083. Epub 2022 Oct 26.
Results Reference
derived
Links:
URL
https://www.teamtrial.org.au/
Description
TEAM study website

Learn more about this trial

Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

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