Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation

Critically Ill, Mechanically Ventilated Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133377
• Other study ID #: TEAM U1111-1195-3567
• Status: Completed
• Phase: Phase 3
• Start date: February 28, 2018
• Est. completion date: November 10, 2022

Study information

• Verified date: December 2023
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: November 10, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill, Mechanically Ventilated

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Mater Health	Brisbane	Queensland
Australia	Mater Private Hospital	Brisbane	Queensland
Australia	Caboolture Hospital	Caboolture	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	The Prince Charles Hospital	Chermside West	Queensland
Australia	Geelong Hospital - Barwon Health	Geelong	Victoria
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Austin Health	Melbourne	Victoria
Australia	Cabrini Health	Melbourne	Victoria
Australia	Epworth Richmond	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne
Australia	St Vincent's Hospital Melbourne	Melbourne	Victoria
Australia	Western Health	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Fiona Stanley Hospital	Perth	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Alfred Hospital	Prahran	Victoria
Australia	Redcliffe Hospital	Redcliffe	Queensland
Australia	Rockhampton Hospital	Rockhampton	Queensland
Australia	St John of God Hospital	Subiaco	Western Australia
Australia	John Hunter Hospital	Sydney	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales
Australia	Toowoomba Hospital	Toowoomba	Queensland
Australia	Wollongong Hospital	Wollongong	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Germany	The Charité	Berlin
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Klinikum rechts der Isar der Technischen Universität M?nchen	Munich
Ireland	Beacon Hospital	Dublin
Ireland	St Vincent's Hospital	Dublin
Ireland	Galway Hospital	Galway
Ireland	Tallaght Hospital	Tallaght
New Zealand	Auckland City Hospital (CVICU)	Auckland
New Zealand	Auckland City Hospital (DCCM)	Auckland
New Zealand	Waikato Hospital	Hamilton
New Zealand	Tauranga Hospital	Tauranga
New Zealand	Wellington Hospital	Wellington
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	University Hospital Lewisham	Lewisham
United Kingdom	King's College Hospital	London
United Kingdom	Nottingham University Hospitals	Nottingham
United Kingdom	Royal Berkshire Hospital	Reading
United Kingdom	Morriston Hospital	Swansea
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	Queen Elizabeth Hospital Woolwich	Woolwich

Sponsors (5)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	ANZICS Clinical Trials Group, Intensive Care National Audit & Research Centre, Medical Research Institute of New Zealand, National Health and Medical Research Council, Australia

Countries where clinical trial is conducted

Australia,  Germany,  Ireland,  New Zealand,  United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delirium free days	Will be measured using CAM-ICU and RASS score	From date of randomisation until day 28
Other	Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)		Assessed at 180days
Other	Psychological function measured using Hospital Anxiety and Depression scale (HADS)		Assessed at 180days
Other	Psychological function measured using Impact of Event Scale - Revised (IES-R)		Assessed at 180 days
Other	All-cause mortality		From date of randomisation up to 28 days
Other	Days alive and out of hospital according to survival status	Any days spent in rehabilitation or a nursing home counted as days in hospital.	From date of randomisation up to 180 days
Other	Days in hospital, rehabilitation facility or nursing home according to survival status	According to D180 survival status	From date of randomisation up to 180 days
Other	Time from randomisation to ICU discharge		From date of randomisation up to 180 days
Other	Time from randomisation to hospital discharge		From date of randomisation up to 180 days
Primary	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	All-cause mortality		From date of randomisation up to180days.
Secondary	Time from randomisation until death		From date of randomisation unitl date of death from all cause, censored at 180days
Secondary	Ventilator-free days	patients who die prior to day 28 will be assigned zero ventilator-free days	From date of randomisation until day 28
Secondary	ICU-free days	patients who die prior to day 28 will be assigned zero ICU-free days	From date of randomisation until day 28
Secondary	Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)		Assessed at 180days
Secondary	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
Secondary	Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS)		Assessed at 180days

External Links

•   TEAM study website