TEAM
Research type
Research Study
Full 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
IRAS ID
261777
Contact name
Kerrie Gemmill
Contact email
Sponsor organisation
Intensive Care National Audit and Research Centre
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
Summary of Research
Patients who are admitted to the Intensive Care Unit (ICU) with a life-threatening illness often receive invasive mechanical ventilation. This involves a tube inserted into the patient's airway, and attached to a ventilator (breathing machine) to assist with their breathing. However patients receiving this treatment are typically confined to bed (immobilised) with no active exercise. This immobilisation contributes substantially to the development of muscle weakness and wasting (ICU-acquired weakness). In turn, these problems are associated with poor outcomes for patients including increased hospital length of stay, increased mortality after hospital discharge, and impaired long-term functional recovery.
It is now recognised that immobilisation during prolonged invasive mechanical ventilation can be avoided and is a potentially modifiable cause of ICU-acquired weakness. Over the last eight years a multidisciplinary intervention called “early activity and mobilisation” has been developed and tested. Early activity and mobilisation have been demonstrated to be safe and feasible, albeit not routinely part of standard patient care. The TEAM (Treatment of invasively ventilated adults with Early Activity and Mobilisation) study is a multicentre, randomised controlled trial in patients expected to require prolonged mechanical ventilation.
This trial will determine whether early activity and mobilisation delivered during invasive mechanical ventilation increases the number of days’ patients spend alive and out of hospital in the 180 days after randomisation. The trial will recruit 750 patients, and be the largest trial ever conducted of early mobilisation in ICU. The trial will establish whether early activity and mobilisation should become standard care. If the intervention is beneficial the trial will establish a new approach to the management of critically ill patients in the ICU.
Summary of Results
The TEAM trial was an international study led by Prof Carol Hodgson from Monash University, Australia. UK sites recruited 46 patients towards the total 750 patients included in the study internationally.
Background:
Patients who are admitted to the Intensive Care Unit (ICU) with a life-threatening illness often receive invasive mechanical ventilation. This involves a tube inserted into the patient's airway and attached to a ventilator (breathing machine) to assist with their breathing. Patients receiving this treatment often develop muscle weakness and wasting (ICU-acquired weakness) which is associated with longer stays in ICU and hospital and higher risk of death. The TEAM trial investigated whether early mobilisation of patients who are receiving invasive mechanical ventilation improved outcomes compared to the usual level of mobilisation (standard patient care).Design:
The TEAM trial was an international randomised clinical trial. 750 patients (46 from the UK) were randomly assigned to receive early mobilisation, which was performed daily by a physiotherapist and tailored to the individual patient, or the usual level of mobilisation (standard patient care) provided by the participating ICU. The primary outcome was the number of days patients spend alive and out of hospital in the 180 days after randomisation.Results:
The number of days patients included in the study spent alive and out of hospital at 180 days after randomisation did not differ between patients in the early mobilisation group compared with patients in the standard patient care group. The number of adverse events (an untoward medical occurrence) potentially caused by mobilising patients was higher in the early mobilisation group.Conclusions:
In patients receiving invasive mechanical ventilation, early mobilisation did not increase the number days patients spent alive and out of hospital compared with usual level of mobilisation in the ICU and out of hospital and was associated with more adverse events.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
19/LO/0941
Date of REC Opinion
29 Aug 2019
REC opinion
Further Information Favourable Opinion