Webinar Series November 16, 2016

Transcription

1 Webinar Series November 16, 2016 E-CYCLE: Clinical trial of in-bed cycling in elderly, mechanicallyventilated patients Michelle Kho, PhD, PT McMaster University

2 Welcome to the CFN Webinar Series E-CYCLE: Clinical trial of in-bed cycling in elderly, mechanicallyventilated patients John Muscedere Scientific Director Webinar & slides posted on CFN website:

3 Q-&-A session Follows Dr. Kho s presentation Submit your Qs online during presentation We will answer as many Qs as time permits Webinar is recorded and available for viewing online within 1-2 days:

4 Presenter E-CYCLE: Clinical trial of in-bed cycling in elderly, mechanically-ventilated patients Assistant Professor in the School of Rehabilitation Science, Faculty of Health Sciences at McMaster University Physiotherapist for patients in the St. Joseph s Healthcare ICU in Hamilton Adjunct Assistant Professor in the Department of Physical Medicine and Rehabilitation at Johns Hopkins University in Baltimore, MD Research interests include novel early rehabilitation strategies to reduce weakness in ICU patients, knowledge translation, research methodology, and health services and outcomes research Michelle Kho, PhD, PT

5 a pilot RCT of early in-bed cycling in elderly, mechanically ven9lated pa9ents Michelle Kho, PT, PhD on behalf of the E-CYCLE inves:gators November 16, 2016

6 Acknowledgements Restora:ve Therapies for bike loan at Toronto General Hospital Funding Canadian Frailty 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 Ontario Thoracic Society

7 Team Members Inves9gators Dr. Michelle Kho, McMaster/ SJH (PI) Dr. Ian Ball, Western Dr. Karen Burns, St. Michael s Dr. Deborah Cook, McMaster/ SJH Dr. Alison Fox-Robichaud, McMaster/ Hamilton General Dr. Jan Friedrich, St. Michael s Dr. Margaret Herridge, Toronto General Dr. Tim Karachi, McMaster/ Juravinski Dr. Karen Koo, Western/ Swedish Healthcare Mr. Vince Lo, Toronto General Dr. Sunita Mathur, U of Toronto Dr. Marina Mourtzakis, U Waterloo Dr. Joe Pellizzari, McMaster/ SJH Mr. Tom Piraino, McMaster/ SJH Dr. Bram Rochwerg, McMaster/ Juravinski Dr. Jill Rudkowski, McMaster/ SJH Dr. Andrew Seely, U O^awa/ O^awa General Dr. Jean-Eric Tarride, McMaster Methods Centre (Hamilton, ON) Ms. France Clarke, McMaster/ SJH Dr. Aileen Cos:gan, SJH Mr. Alex Molloy, SJH Ms. Janelle Unger, U of Toronto Ms. Devin McCaskell, U of Toronto/ SJH Mr. Mike Ciancone, McMaster/ SJH As of November 11, 2016

8 Team Members Physiotherapists/ Physiotherapist Assistants; RCs; RAs St. Joseph s Healthcare: Daana Ajami, Laura Camposilvan, Magda McCaughan, Kristy Obrovac, Chris:na Murphy, Wendy Perry, Diana Hatzoglou, Miranda Prince, Bashir Versi; RCs France Clarke, Alex Molloy Hamilton Health Sciences Juravinski: Leigh Ann Niven, Tania Bri^ain, Jessica Temesy, Andrea Galli, Chris Farley, Shivaun Davidson, Helen Bishop, Shannon Earl, Chelsea Hale, Gillian Manson; RC Tina Millen Hamilton Health Sciences General: Ashley Eves, Annie Newman, Judi Rajczak, Julie Reid, Elise Loreto, Sarah Lohonyai, Jennifer Duley, Sue Mahler, Ma^ McCaffrey, Jessica Pilon- Bignell; RC Ellen McDonald Toronto General: Vince Lo, Sunita Mathur, Gary Beauchamp, Anne-Marie Bourgeois, Nathalie Côté, Sherry Harburn, Adriane Lachmaniuk, Megan Hudson, Sophie Mendo, Teresa Torres; RC Andrea Ma^e; RAs Jaimie Archer, Daniel Chen, Cris:an Urrea, Lia Stenyk London Health Sciences: Kristen Abercombie, Jennifer Curry, Erin Blackwell-Knowles, Tania Larsen, Jennifer Jackson; RC Eileen Campbell; RA Rebecca Rondinelli St. Michael s Hospital: Deanna Feltracco, Chris:ne Leger, Sarah Brown, Diana Horobetz, Verity Tulloch, Anna Michalski, Natalia Zapata; RCs Orla Smith, Kur:s Salway, Gyan Sandhu ORawa General: Rachel Goard, Josee Lamontagne, Michelle Cummings, Sarah (Sal) Pa^en; RCs Rebecca Porteous, Heather Langlois, Irene Watpool, Brige^e Gomes, Shelley Acres As of November 11, 2016

9 Learning Objec9ves 1. Understand the impact of cri:cal care on physical func:on in elderly survivors 2. Understand the natural history of muscle atrophy and strength loss immediately following ICU admission 3. Understand the role of early rehabilita:on trials for cri:cally ill elderly pa:ents

10 1. WHAT IS THE IMPACT OF CRITICAL CARE ON PHYSICAL FUNCTION IN ELDERLY SURVIVORS?

11 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.

12 What happens to elderly pa9ents a\er the ICU?

13 Epidemiology of disability in elderly ICU survivors 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% Disability is common in elderly who survive cri9cal care Brummel et al., Crit Care Med. 2015; 43:

14 Physical func9on pre- and post- sepsis (higher scores, worse func9on) Iwashyna et al., JAMA. 2010;304(16):

15 Func9onal disability in elderly survivors pre- and post- ICU Year before cri9cal illness (n=291) Severe disability (26.5%) Year a"er cri9cal illness (n=221) Severe disability (51.1%) Mild to moderate disability (44.0%) Mild to moderate disability (28.1%) Minimal disability (29.6%) Minimal disability (20.8%) Time before ICU admission, months Time a"er ICU admission, months Pre-ICU disability ICU / Hospital Post-ICU disability Ferrante et al., JAMA Int Med. 2015;175(4):

16 Increasing disability in elderly post-mv Ac9vi9es of Daily Living Mobility Barnato et al., AJRCCM. 2011;183:

17 Towards RECOVER: Prospec9ve 1-year follow-up of 391 ICU survivors Senng: 10 Canadian medical-surgical ICUs Popula:on: Adult ICU survivors MV >=7 d ICU Admission ICU Discharge Outcomes: Func:onal Independence Measure (FIM) Impact of Event Scale (PTSD) Beck Depression Inventory Clinical Course Median (IQR) ICU LOS: 16 (11-27); Hospital LOS: 49 7 days 3 months 6 months 12 months Hip & shoulder girdle weakness; poor coordina:on, gait, & balance 40% able to 7 days post-icu ~ 1 in 5 reported important symptoms of PTSD ~ 1 in 5 reported moderate to severe depressive symptoms Herridge et al, AJRCCM In press. Available online March 2016.

18 No impact of Admission Dx or APACHE II score ICU LOS and age predicted 7 days 7 days predicted 1 year recovery FIM Score 126 >60 50 <40 18 Totally independent Modified Independence Moderate Assistance Max to Total Assistance Totally dependent Herridge et al, AJRCCM In press. Available online March 2016.

19 Projected incidence of non-cardiac surgery, mechanically ventilated adults é40% More ICU survivors at risk for post-icu impairments Needham et al., Crit Care Med (3):574-9.

20 2. WHAT IS THE NATURAL HISTORY OF MUSCLE WEAKNESS AND STRENGTH LOSS IMMEDIATELY FOLLOWING ICU ADMISSION?

21 1. Quadriceps muscle cross sec9onal area decreases quickly in the ICU Puthucheary et al., JAMA (15):

22 2. Within 7 days of ICU admission, involuntary quadriceps force is very low ~ day 7 Vivodtzev et al., Cri:cal Care :431.

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

24 Summary: Why is rehab in the ICU important? 1. Elderly ICU survivors experience important long-term physical dysfunc:on 2. The 1 st 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?

25 3. WHAT IS THE ROLE OF EARLY REHABILITATION TRIALS FOR CRITICALLY ILL ELDERLY PATIENTS?

26 Interven9ons to improve physical func9on post-icu In-ICU Post-ICU Post-Hospital Ineffec9ve Therapies Effec9ve Therapies Interven9on Type: nexercise / Physical therapy; nnon-exercise X = measurement 9me point Calvo-Ayala et al., Chest. 2013; 144(5):

27 Special considera9ons for E-CYCLE Is it feasible to conduct early rehabilita:on with cri:cally ill, elderly pa:ents? Few rehabilita:on studies in cri:cally ill, elderly pa:ents Elderly pa:ents underrepresented in cri:cal care clinical trials 1 1 Cooke et al., Crit Care Med 2010;38(6):

28 86 pts, before/ auer study Control: PT started auer pneumonia resolu:on (> 7d) Interven9on: PT started upon ICU admission Early PT: Shorter ICU LOS (12.0 vs 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 Chigira et al., J Phys Ther Sci :

29 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 Lancet : RCT: In-bed cycling started ICU day 14 improved 6-minute walk test distance at hospital discharge Crit Care Med (9): Ques9on: Can we ini:ate in-bed cycling with pa:ents earlier in their ICU stay, and will it improve pa:ent outcomes?

30 CYCLE: Cri9cal Care Cycling to Improve Lower Extremity Strength CYCLE Prepara:on phase TryCYCLE: Phase II open label study CYCLE RCT: Phase II pilot randomized trial CYCLE RCT: Phase III randomized trial ICAN Rehab Survey development: pt, family, clinician sa:sfac:on with rehabilita:on CYCLE-R Systema:c Review Uni-CYCLE 1 center, 33 pt prospec:ve cohort Design the interven:on; select outcomes; assess fidelity, safety, sa:sfac:on, and acceptability submi;ed 7 center, 66 pt pilot RCT Feasibility BMJ Open 2016 (protocol paper) Mul:center RCT CYCLE$ Economic evalua:on BICYCLE Behavioural Interven:on for Knowledge Transla:on Retrospec:ve chart audit JCC 2015

31 RESEARCH QUESTION: Is it feasible to enroll newly mechanically ven:lated elderly adults in a mul:-centre pilot RCT of early inbed cycling plus rou:ne physiotherapy versus rou:ne physiotherapy alone to inform a larger RCT?

32 E-CYCLE Pilot RCT Feasibility Outcomes 1. Accrual: Following orienta:on, the overall average accrual rate will be 3 pts/ month (1 pt/ month/ site) 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

33 Study Schema ICU Admission Study Entry 4 d MV Awake ICU Discharge Hospital Discharge Clinical Course Intubated 30 min cycling + Rou:ne PT or Rou:ne PT Rou:ne PT Study Outcome Assessments Outcomes #1 (short) Outcomes #2 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

34 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!

35 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 1 st 4 days of MV (see next slide)!

36 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 SpO 2 <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

37 E-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 *= Primary outcome for full RCT

38 Survey and Future Webinars Brief survey will pop up on your screen within next few seconds. Your responses provide us with feedback on how we can improve the webinar series. Upcoming webinars register using the link below Wednesday, November 30, 2016 at 12 noon ET Improve decision making involving frail elderly and caregivers on location of care results of CFN-funded Core Grant France Légaré, Université Laval Wednesday, December 7, 2016 at 12 noon ET Piloting of volunteer and healthcare provider partnership to provide navigation for rural, frail older adults results of CFN-funded Catalyst Grant Wendy Duggleby, University of Alberta, Barbara Pesut, University of British Columbia Wednesday, December 14, 2016 at 12 noon ET Talk to me: seriously ill patients' views on physician behaviours that influence the quality of end-of-life communication results of CFN-funded Core Grant John You, McMaster University Webinar slides & video available after the webinar at: cfn-nce.ca/news-and-events/webinars