Kho ECYCLE (Sep-29-2015) submitted.pptx

Michelle Kho, PT, PhD [email protected] 15-‐09-‐29

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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

HHS – General •  Ashley Eves, Annie Newman, Judi Rajczak, Julie Reid, Elise Loreto

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


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MUSCLE WEAKNESS IN ICU STARTS EARLY AND IMPACTS MORTALITY

Puthucheary et al., JAMA. 2013. 310(15):1591-‐600.

1. Quadriceps muscle cross sec9onal area decreases quickly in the ICU

2. Within 7 days of ICU admission, involuntary quadriceps force is very low

~ day 7

Vivodtzev et al., Cri=cal Care. 2014. 18:431.

3. Pa9ents developing ICUAW have longer LOS & MV, higher costs, and higher 1-‐year mortality

Last MRC in ICU > 48

Last MRC in ICU 36 to 47

Last MRC in ICU <36

Hermans et al., AJRCCM. 2014; 190(4):410-‐420. ICUAW = ICU-‐acquired weakness MRC = Medical Research Council

Summary: Why is rehab in the ICU important? 1.  Elderly ICU survivors experience important

long-‐term physical and cogni=ve dysfunc=on 2.  The 1st 10 days of bedrest are crucial:

–  Muscle strength losses –  Cardiovascular decondi=oning

3.  Rehabilita=on is essen=al to pa=ents’ recovery – how early can we start?

Calvo-‐Ayala et al., Chest. 2013; 144(5):1469–1480

Effec9v

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Interven9ons to improve physical func9on post-‐ICU In-‐ICU Post-‐ICU Post-‐Hospital

Interven9on Type: nExercise / Physical therapy; nNon-‐exercise X = measurement 9me point


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Chigira et al., J Phys Ther Sci. 2015. 27: 2053-‐2056.

•  86 pts, before/ aier study •  Control: PT started aier

pneumonia resolu=on (> 7d) •  Interven9on: PT started upon

ICU admission •  Early PT:

–  Shorter ICU LOS (12.0 vs. 15.5 days, p<0.01)

–  Slower decline in FIM score (p<0.01)

–  No difference in d/c FIM, hospital LOS

Strengths ü  Elderly cri=cal care survivors ü  Func=on at discharge Limita9ons •  No severity of illness

informa=on •  No informa=on on mechanical

ven=la=on or other ICU interven=ons

Ra9onale for E-‐CYCLE •  RCT: PT and OT started within 1.5 days of intuba=on improves independence at hospital discharge

– Main difference: 19.2 minutes/ day during MV

•  RCT: In-‐bed cycling started ICU day 14 improved 6-‐minute walk test distance at hospital discharge

•  Ques9on: Can we ini=ate in-‐bed cycling with pa=ents earlier in their ICU stay, and will it improve pa=ent outcomes?

Crit Care Med. 2009. 37(9): 2499-‐2505.

Lancet. 2009. 373: 1874-‐1882.

Early cycling in the ICU – emerging evidence

•  No increase in cardiac output or O2 consump=on in MV pa=ents1

•  OK w/ vasoac=ve infusions1

•  Can start within 3 days in pa=ents with sepsis2

Picture courtesy of Ruy Pires-‐Neto, PT, Brazil 1Pires-‐Neto et al., PLoS One 2013;8:e74182.

2Parry et al., J Crit Care 2014. 29:695 e1-‐7. Kho et al., Journal of Cri=cal Care. 2015. In press.

•  181 pa=ents, 541 cycling sessions in 16-‐bed MICU

•  Median ICU admit to first –  PT = 2 days; 4 sessions –  Cycling = 4 days; 2 sessions; 25 minutes/ session

•  Therapies on cycling days –  Mechanical ven=la=on – 80% –  Vasopressors – 8% –  CRRT – 7%

•  Safety events –  1/541 (0.2%)

Strengths ü  Largest cohort of cycling sessions

to-‐date ü  Prospec=ve safety data ü  Cycling as part of rou=ne care Limita9ons •  Retrospec=ve clinical data •  No informa=on on cycling

indica=on •  No func=onal outcome data

CYCLE: Cri9cal Care Cycling to Improve Lower Extremity Strength

TryCYCLE: Phase II open label study

1 center, 33 pt prospec=ve cohort • Design the interven=on; select outcomes; assess fidelity, safety, sa=sfac=on, and acceptability ✔

Submi6ed

CYCLE pilot: Phase II randomized pilot

7 center, 60 pt pilot RCT • Feasibility, mechanisms Enrolling NCT02377830

CYCLE RCT: Phase III randomized trial

Mul=center RCT

BICYCLE

Behavioural Interven=on for Knowledge Transla=on

CYCLE$

Economic evalua=on

CYCLE Prepara=on phase

Survey development: pt, family, clinician sa=sfac=on with rehabilita=on

Retrospec=ve chart audit ✔ JCC 2015

CYCLE-‐R

Systema=c Review

Uni-‐CYCLE

ICAN Rehab

Special considera9ons for E-‐CYCLE

•  Is it feasible to conduct early rehabilita=on with cri=cally ill, elderly pa=ents? – Few rehabilita=on studies

•  Elderly pa=ents underrepresented in cri=cal care clinical trials1

1Cooke et al., Crit Care Med 2010;38(6):1450-‐1457.


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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 !


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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

•  36% of E-‐CYCLE target sample size

Kho ECYCLE (Sep-29-2015) submitted.pptx

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