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A Binational Multicenter Pilot Feasibility Randomized Controlled Trial of Early Goal-Directed Mobilization in the ICU*

Hodgson, Carol L. PT, PhD, (Chair); Bailey, Michael PhD; Bellomo, Rinaldo MD; Berney, Susan PT, PhD; Buhr, Heidi RN; Denehy, Linda PT, PhD; Gabbe, Belinda PhD; Harrold, Megan PT, PhD; Higgins, Alisa PT; Iwashyna, Theodore J. MD, PhD; Papworth, Rebecca PT; Parke, Rachael PhD; Patman, Shane PhD; Presneill, Jeffrey MD, PhD; Saxena, Manoj MD; Skinner, Elizabeth PhD; Tipping, Claire PT; Young, Paul MD; Webb, Steven MD, PhD

doi: 10.1097/CCM.0000000000001643
Clinical Investigations

Objectives: To determine if the early goal-directed mobilization intervention could be delivered to patients receiving mechanical ventilation with increased maximal levels of activity compared with standard care.

Design: A pilot randomized controlled trial.

Setting: Five ICUs in Australia and New Zealand.

Participants: Fifty critically ill adults mechanically ventilated for greater than 24 hours.

Intervention: Patients were randomly assigned to either early goal-directed mobilization (intervention) or to standard care (control). Early goal-directed mobilization comprised functional rehabilitation treatment conducted at the highest level of activity possible for that patient assessed by the ICU mobility scale while receiving mechanical ventilation.

Measurements and Main Results: The ICU mobility scale, strength, ventilation duration, ICU and hospital length of stay, and total inpatient (acute and rehabilitation) stay as well as 6-month post-ICU discharge health-related quality of life, activities of daily living, and anxiety and depression were recorded. The mean age was 61 years and 60% were men. The highest level of activity (ICU mobility scale) recorded during the ICU stay between the intervention and control groups was mean (95% CI) 7.3 (6.3–8.3) versus 5.9 (4.9–6.9), p = 0.05. The proportion of patients who walked in ICU was almost doubled with early goal-directed mobilization (intervention n = 19 [66%] vs control n = 8 [38%]; p = 0.05). There was no difference in total inpatient stay (d) between the intervention versus control groups (20 [15–35] vs 34 [18–43]; p = 0.37). There were no adverse events.

Conclusions: Key Practice Points: Delivery of early goal-directed mobilization within a randomized controlled trial was feasible, safe and resulted in increased duration and level of active exercises.

Supplemental Digital Content is available in the text.

1Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

2Alfred Hospital, Melbourne, VIC, Australia.

3Austin Health, Heidelberg, VIC, Australia.

4The University of Melbourne, Melbourne, VIC, Australia.

5Royal Prince Alfred Hospital, Camperdown, NSW, Australia.

6Monash University, Melbourne, Melbourne, VIC, Australia.

7Curtin University, Bentley, WA, Australia.

8University of Michigan, Ann Arbor, MI.

9Center for Clinical Management Research, VA Ann Arbor Health System, Ann Arbor, MI.

10St Vincent’s Hospital, Melbourne, VIC, Australia.

11Auckland City Hospital/Cardiovascular Intensive Care Unit, Auckland City, New Zealand.

12Fremantle Hospital, Fremantle, WA, Australia.

13Royal Brisbane and Women’s Hospital, Herston, QLD, Australia.

14The George Institute for Global Health, Sydney, NSW, Australia.

15Western Hospital, Footscray, VIC, Australia.

16Wellington Hospital, Wellington, New Zealand.

17Royal Perth Hospital, Subiaco WA, Australia.

*See also p. 1239.

Additional members of The Trial of Early Activity and Mobilization Study are listed in Appendix 1.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

The Trial of Early Activity and Mobilization (TEAM) study is a collaboration between the Australian and New Zealand Intensive Care Society (ANZICS) Clinical Trials Group and the Australian and New Zealand Intensive Care Research Centre. The members of the Writing Committee for the TEAM study take responsibility for the content of this article.

Drs. Hodgson, Berney, Harrold, Higgins, Papworth, Parke, Patman, and Tipping’s institutions received funding from Monash University Strategic Grant Scheme. The remaining authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: carol.hodgson@monash.edu

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