TEAM-RCT: TEAM: A Trial of Early Activity and Mobility in ICU
Study Details
Study Description
Brief Summary
Patients in the intensive care unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weaknesses even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, delay functional recovery and delay their return home and to work. Weakness may be avoided with simple strategies of early exercise in ICU. This pilot study aims to test the hypothesis that early mobilisation may improve functional recovery in this patient group and gather pilot data to support a larger randomised trial across Australia and New Zealand.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Patients who are admitted and treated in the intensive care unit (ICU) generally have potentially reversible critical illness. While many patients survive, substantial proportions of patients fail to recover completely and do not return to their pre-morbid level of health. Critically ill patients receive mechanical ventilation, as a lifesaving intervention, but this is routinely managed with deep sedation and immobility, which results in prolonged periods of bed rest. Severe muscle weakness, termed ICUAW, is common and associated with prolonged duration of mechanical ventilation and hospital stay in the ICU, as well as poor recovery of physical function. Early mobilisation, exercising patients while they are still receiving mechanical ventilation, has been proposed as a candidate intervention to prevent ICU acquired weakness (ICUAW). Observational studies indicate that early mobilisation is not used routinely in critically ill patients in Australia and New Zealand. TEAM is a pilot RCT designed to obtain data to assist in the planning of an adequately powered RCT that will test the hypothesis that early mobilisation of critically ill patients improves one or more functional outcomes, quality of survival, and proportion of patients who survive.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: early mobilisation intervention of early mobilisation |
Behavioral: Early mobilisation
Other Names:
|
| No Intervention: Control Standard care |
Outcome Measures
Primary Outcome Measures
- Highest daily level of activity measured using the ICU mobillity scale [Duration of ICU stay (an average of 10 days)]
ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)
- Total Duration of Active Mobilisation [Radomisation to removal of invasive ventilation (an average of 7 days)]
- Mean (or Median) Daily Duration of Active Mobilisation [Randomisation to removal of invasive ventilation (daily for an average of 7 days)]
Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.
- Total Duration of Active Mobilisation [Randomisation to ICU discharge, an average of 10 days]
Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours
- Mean (or Median) Daily Duration of Active Mobilisation [Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days]
Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)
- Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day [Randomisation to Extubation, an average of 7 days]
Measured using the ICU mobility scale (0-10)
Secondary Outcome Measures
- Physical Function [At 6 months from randomisation]
Highest level of activity, measured using the IADL
- Recruitment Rates [Entirety of Study]
- Staff Utilisation Costs [ICU admission (approximately 10 days)]
Number of staff required for mobilisation, minutes spent with the patient on active mobilisation activities, and type of staff such as assistant, physiotherapist or nurse, and specific equipment used during mobilisation ie: tilt table/standing frame.
- Ventilator and IC free days at Day 28 [Randomisation to Day 28]
Intensive care free defined as ward ready; free of inotropes, RRT and mechanical ventilation for 24 hours and remaining free of these supports until the time of actual ICU discharge
- Health related quality of life [6 Months after ICU admission]
EQ5D measured using a trained, blinded assessor via telephone interview
- Return to previous work level [At 6 months from randomisation]
Has the participant returned to the work level prior to critical illness?
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults > or + to 18 years old admitted to the ICU
-
Invasively ventilated and expected to be ventilated the day after tomorrow
-
Written informed consent from person responsible/ net of kin (or consent as per individual HREC if delayed or telephone consent is acceptable)
Exclusion Criteria:
- INSTABILITY A. Cardiovascular
-
Unresolved rhythm disturbance with any bradycardia requiring pharmacological support
-
Any tachycardia with ventricular rate > 150 beats/min
-
Lactacte > 4.0 due to inadequate tissue perfusion
-
Any external mechanical cardiovascular support (eg. VA ECMO or intra-aortic balloon pump)
-
Norad > 0.2mcg/kg/min (or unit equivalent) or any dose of norad between 0.1 and 0.2mcg/kg/min with more than a 25% increase in last 6 hours
-
Cardiac index < 2.0L/min/m^2
- Respiratory
-
FiO2 > 0.6
-
PEEP > 15
-
Requirement for hypoxaemic rescue interventions eg. NO, prone, ECMO, prostacyclin, HFOV
-
RR > 45
-
Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage, encephalitis, or moderate to severe traumatic brain injury
-
Proven or suspected actue spinal cord injury
-
Proven or suspected Guillain-Barre Syndrome
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Second or subsequent ICU admission during a single hospital admission
-
Unable to follow simple verbal commands in English
-
Death inevitable and imminent
-
Inability to walk without assistance of another person prior to onset of acute illness necessitating ICU admission
-
Cognitive impairment prior to current acute illness
-
Agitation which int he opinion of the treating clinician precludes safe implementation of EGDM
-
Written rest in bed orders due to documented injury or process the precludes mobilisation such as suspected or proven instability of spine or pelvis
-
In the opinion of the treating clinician it is unsafe to commence EGDM
-
Has met all the inclusion criteria with no concomitant exclusion criteria for a period of more than 48 hours
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Austin Hospital | Heidelberg | Victoria | Australia | 3084 |
| 2 | The Alfred Hospital | Melbourne | Victoria | Australia | 3004 |
| 3 | Fremantle Hospital | Fremantle | Western Australia | Australia | 6160 |
| 4 | Auckland CIty Hospital CVICU | Grafton | Auckland | New Zealand | 1023 |
| 5 | Wellington Hospital | Newtown | Wellington | New Zealand | 6021 |
Sponsors and Collaborators
- Australian and New Zealand Intensive Care Research Centre
- Australian and New Zealand Intensive Care Society Clinical Trials Group
Investigators
- Study Chair: Carol L Hodgson, PhD, Australian and New Zealand Intensive Care Research Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- NCT01927510