Michelle Kho, PT, PhD [email protected]150929 1 a pilot RCT of early inbed cycling in elderly, mechanically ven9lated pa9ents 3 rd Annual TVN Conference September 29, 2015 Michelle Kho, PT, PhD Assistant Professor, School of Rehabilita9on Science Canada Research Chair in Cri9cal Care Rehabilita9on and Knowledge Transla9on Acknowledgements • Restora=ve Therapies for bike loan at Toronto General Hospital • Funding – Technology Evalua=on in the Elderly Network – Canada Research Chairs – Canada Founda=on for Innova=on – Ontario Research Fund Research Infrastructure Program – Canadian Ins=tutes for Health Research – Canadian Respiratory Research Network Emerging Research Leaders Ini=a=ve Team Members Physiotherapists/ Knowledge Users St. Joseph’s Healthcare • Daana Ajami, Magda McCaughan , Chris=na Murphy, Kristy Obrovac, Laura Camposilvan, Bashir Versi, Miranda Prince HHS – Juravinski • Leigh Ann Niven , Tania BriUain, Andrea Galli, Jessica Temesy HHS – General • Ashley Eves, Annie Newman, Judi Rajczak, Julie Reid , Elise Loreto Toronto General (coPIs) • Vince Lo , Sunita Mathur, PT, PhD, Gary Beauchamp, Anne Marie Bourgeois, Sherry Harburn, Megan Hudson, Teresa Torres Inves9gators • Dr. Michelle Kho, McMaster/ SJH (PI) • Dr. Karen Burns, St. Mike’s • Dr. Deborah Cook, McMaster/ SJH • Dr. AlisonFox Robichaud, McMaster, Hamilton General • Dr. Margaret Herridge, Toronto General • Dr. Tim Karachi, McMaster, Juravinski • Dr. Bram Rochwerg, McMaster, Juravinski • Dr. Karen Koo, Western / Swedish Healthcare • Dr. Marina Mourtzakis, U Waterloo • Dr. Joe Pellizzari, McMaster/ SJH • Dr. Jill Rudkowski, McMaster/ SJH • Dr. Andrew Seely, U of OUawa / OUawa General • Dr. JeanEric Tarride, McMaster Methods Centre (Hamilton, ON) • Ms. France Clarke, McMaster/ SJH • Mr. Alex Molloy, SJH • Elderly receiving more life support interven=ons • Mechanical ven=la=on • Vasopressors • Renal replacement • Improved survival LeRolle et al., Crit Care Med 2010;38(1):5964. Brummel et al., Crit Care Med. 2015; 43:1265–1275. Disability < 3 months > 6 months Mobility 14% 87% Ac=vi=es of daily living (prevalence) 33% 58% 12% 97% Epidemiology of disability in elderly ICU survivors Disability is common in elderly who survive cri9cal care Needham et al., Crit Care Med. 2005. 33(3):574-9. 40% Projected incidence of non-cardiac surgery, mechanically ventilated adults More ICU survivors at risk for post-ICU impairments
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a pilot RCT of early in-‐bed cycling in elderly, mechanically ven9lated pa9ents
3rd Annual TVN Conference September 29, 2015
Michelle Kho, PT, PhD Assistant Professor, School of Rehabilita9on Science Canada Research Chair in Cri9cal Care Rehabilita9on and Knowledge Transla9on
Acknowledgements • Restora=ve Therapies for bike loan at Toronto General Hospital
• Funding – Technology Evalua=on in the Elderly Network – Canada Research Chairs – Canada Founda=on for Innova=on – Ontario Research Fund Research Infrastructure Program
– Canadian Ins=tutes for Health Research – Canadian Respiratory Research Network Emerging Research Leaders Ini=a=ve
Team Members Physiotherapists/ Knowledge Users St. Joseph’s Healthcare • Daana Ajami, Magda McCaughan, Chris=na Murphy, Kristy Obrovac, Laura Camposilvan, Bashir Versi, Miranda Prince
HHS – Juravinski • Leigh Ann Niven, Tania BriUain, Andrea Galli, Jessica Temesy
Toronto General (co-‐PIs) • Vince Lo, Sunita Mathur, PT, PhD, Gary Beauchamp, Anne-‐Marie Bourgeois, Sherry Harburn, Megan Hudson, Teresa Torres
Inves9gators • Dr. Michelle Kho, McMaster/ SJH (PI) • Dr. Karen Burns, St. Mike’s • Dr. Deborah Cook, McMaster/ SJH • Dr. Alison-‐Fox Robichaud, McMaster, Hamilton General • Dr. Margaret Herridge, Toronto General • Dr. Tim Karachi, McMaster, Juravinski • Dr. Bram Rochwerg, McMaster, Juravinski • Dr. Karen Koo, Western / Swedish Healthcare • Dr. Marina Mourtzakis, U Waterloo • Dr. Joe Pellizzari, McMaster/ SJH • Dr. Jill Rudkowski, McMaster/ SJH • Dr. Andrew Seely, U of OUawa / OUawa General • Dr. Jean-‐Eric Tarride, McMaster Methods Centre (Hamilton, ON) • Ms. France Clarke, McMaster/ SJH • Mr. Alex Molloy, SJH
• Elderly receiving more life support interven=ons • Mechanical
ven=la=on • Vasopressors • Renal
replacement • Improved survival
LeRolle et al., Crit Care Med 2010;38(1):59-‐64.
Brummel et al., Crit Care Med. 2015; 43:1265–1275.
Disability < 3 months > 6 months
Mobility 14% -‐ 87%
Ac=vi=es of daily living (prevalence) 33% -‐ 58% 12% -‐ 97%
Instrumental ac=vi=es of daily living 22% -‐ 45%
Cogni=ve impairment 56%
Epidemiology of disability in elderly ICU survivors
Disability is common in elderly who survive cri9cal care
Needham et al., Crit Care Med. 2005. 33(3):574-9.
é40%
Projected incidence of non-cardiac surgery, mechanically ventilated adults
More ICU survivors at risk for post-ICU impairments
RESEARCH QUESTION: In medical-‐surgical ICU pa=ents, is it safe and feasible to ini=ate 30 minutes of in-‐bed leg cycling within 4 days of star=ng mechanical ven=la=on and through the ICU stay?
7.13 km!
RESEARCH QUESTION: Is it feasible to enroll newly mechanically ven=lated elderly adults in a mul=-‐centre pilot RCT of early in-‐bed cycling plus rou=ne physiotherapy versus rou=ne physiotherapy alone to inform a larger RCT?
Awake
Outcomes #1 (short)
Study Schema
30 min cycling + Rou=ne PT or Rou=ne PT
Clinical Course
Study Outcome Assessments
ICU Admission
Rou=ne PT
Study Entry ≤4 d MV
Intubated
ICU Discharge
Outcomes #2
Hospital Discharge
Outcomes #3
• Randomized interven=on 5d/ wk un=l ICU d/c or 28 days • If pa=ents in cycling arm -‐> d/c cycling if pa=ent can march on the spot x 2 days
E-‐CYCLE Pilot RCT Feasibility Outcomes
1. Accrual: Following orienta=on, the overall average accrual rate will be 3 pts/ month
2. Protocol viola9ons: The cycling protocol can be implemented with <20% protocol viola=ons
3. Outcome Measures: >80% of outcomes will be measured as scheduled
4. Blinded Outcome Assessment: >80% of outcomes at hospital discharge will be assessed by personnel blinded to group alloca=on
E-‐CYCLE inclusion criteria
• Adult patient > 65 years old • Invasively mechanically ventilated ��4 days • Expected additional 2 day ICU stay • Walked independently pre-hospital • ICU length of stay ��7 days !
Exclusion criteria a. Pre-hospital inability to follow simple commands in
English at baseline b. Acute conditions impairing ability to cycle c. Acute proven or suspected neuromuscular weakness d. Temporary pacemaker e. Expected hospital mortality >90% f. Equipment unable to fit patient’s body dimensions g. Palliative goals of care h. Pregnancy i. Specific surgical exclusion per surgical or ICU team j. Physician declines k. Cycling exemptions not cleared in the 1st 4 days of MV
(see next slide) !
Daily cycling exemp9ons Cardiovascular 1. Any increase in vasopressor/ inotrope within last 2 hours 2. Active MI, or unstable/ uncontrolled arrhythmia per ICU team 3. MAP <60 or >110 mmHg within the last 2 hours or per ICU team
limits 4. HR <40 or >140 bpm within the last 2 hours
Respiratory 1. Persistent SpO2 <88% within the last 2 hours or out of
range per ICU team 2. Neuromuscular blocker within last 4 hours
Other 1. Severe agitation (RASS >2 [or equivalent]) within last 2 hours 2. Uncontrolled pain 3. Change in goals to palliative care 4. Team perception that in-bed cycling is not appropriate despite
absence of above criteria
CYCLE Pilot RCT Outcome measures By PTs: • Physical Func9on Test for ICU* • Muscle, quads strength • 2 min walk, 30s sit to stand By Research Coordinator: • RASS, CAM-‐ICU • Pa=ent-‐reported func=on • Katz ADL • EQ5D QOL; Intensive care psychological screening; Alpha-‐FIM (to come)
*= Primary outcome for full RCT
Delivering the interven9on: Considera9ons
• Front-‐line engagement of PTs is cri;cal – For a future mul=-‐centre RCT – For Knowledge transla=on post-‐RCT
• Cycling is a tool, not a replacement for PT – Concerns about how cycling impacts other mobility ac=vi=es
– Limited pa=ent endurance / reserve
• Early cycling is very exci=ng – Especially with sedated pa=ents
E-‐CYCLE Pilot RCT Progress to-‐date Site Bike
Training Ethics Contracts Enrollment
St. Joe’s Hamilton ✔ ✔ ✔ 9 as of Sept 28
Juravinski Hamilton ✔ ✔ ✔ 1 as of Sept 28
Hamilton General ✔ ✔ ✔ 1 as of Sept 28
Toronto General ✔ In revision In
progress
Pending ethics &
contracts
• To-‐date, we have trained over 20 front-‐line physiotherapists • Embedded redundancy to ensure a PT is always available to bike or assess outcomes