TEAM: A Trial of Early Activity and Mobility in ICU

Critically Ill Clinical Trial

— TEAM-RCT  

Official title:

Pilot Randomised Controlled Trial of Early Mobilisation in Critically Ill Patients to Improve Functional Recovery and Quality of Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927510
• Other study ID #: NCT01927510
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2013
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. 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

B. Respiratory

• FiO2 > 0.6

• PEEP > 15

• Requirement for hypoxaemic rescue interventions eg. NO, prone, ECMO, prostacyclin, HFOV

• RR > 45

2. Proven or suspected actue brain injury such as stroke, sub-arachnoid haemorrhage, encephalitis, or moderate to severe traumatic brain injury

3. Proven or suspected actue spinal cord injury

4. Proven or suspected Guillain-Barre Syndrome

5. Second or subsequent ICU admission during a single hospital admission

6. Unable to follow simple verbal commands in English

7. Death inevitable and imminent

8. Inability to walk without assistance of another person prior to onset of acute illness necessitating ICU admission

9. Cognitive impairment prior to current acute illness

10. Agitation which int he opinion of the treating clinician precludes safe implementation of EGDM

11. Written rest in bed orders due to documented injury or process the precludes mobilisation such as suspected or proven instability of spine or pelvis

12. In the opinion of the treating clinician it is unsafe to commence EGDM

13. Has met all the inclusion criteria with no concomitant exclusion criteria for a period of more than 48 hours

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Behavioral:
• Early mobilisation

Locations

Country	Name	City	State
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	The Austin Hospital	Heidelberg	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
New Zealand	Auckland CIty Hospital CVICU	Grafton	Auckland
New Zealand	Wellington Hospital	Newtown	Wellington

Sponsors (2)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Australian and New Zealand Intensive Care Society Clinical Trials Group

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highest daily level of activity measured using the ICU mobillity scale	ICU Mobility Scale - ranges from 0 (Nothing/Lying in Bed) to 10 (Walking Independently without a Gait Aid)	Duration of ICU stay (an average of 10 days)
Primary	Total Duration of Active Mobilisation		Radomisation to removal of invasive ventilation (an average of 7 days)
Primary	Mean (or Median) Daily Duration of Active Mobilisation	Measured in minutes, any mobilisation activity where the patient can use their own muscle force to assist the movement.	Randomisation to removal of invasive ventilation (daily for an average of 7 days)
Primary	Total Duration of Active Mobilisation	Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours	Randomisation to ICU discharge, an average of 10 days
Primary	Mean (or Median) Daily Duration of Active Mobilisation	Pt will be free of Mechanical Ventilation, Vasopressors and Continuous Renal Replacement Therapy for 24 Hours (approximately 10 days)	Randomisation to Time of Final Listing for Ward Discharge, an average of 10 days
Primary	Proportion of Patients achieving each Category of Highest Level of Mobilisation on Each Day	Measured using the ICU mobility scale (0-10)	Randomisation to Extubation, an average of 7 days
Secondary	Physical Function	Highest level of activity, measured using the IADL	At 6 months from randomisation
Secondary	Recruitment Rates		Entirety of Study
Secondary	Staff Utilisation Costs	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.	ICU admission (approximately 10 days)
Secondary	Ventilator and IC free days at 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	Randomisation to Day 28
Secondary	Health related quality of life	EQ5D measured using a trained, blinded assessor via telephone interview	6 Months after ICU admission
Secondary	Return to previous work level	Has the participant returned to the work level prior to critical illness?	At 6 months from randomisation