best evidence chest pt mobility...

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Michelle Kho, PT, PhD [email protected] 1

Physiotherapy in the ICU: Best Evidence

December 17, 2014 Michelle Kho, PT, PhD Canada Research Chair in CriAcal Care RehabilitaAon and Knowledge TranslaAon Assistant Professor, RehabilitaAon Sciences, McMaster University Adjunct Assistant Professor, Physical Medicine and RehabilitaAon, Johns Hopkins University

School of RehabilitaAon Science Reaching Further

Financial Interest Disclosure

•  I have no conflict of interest. •  Funding – Canada Research Chairs, Canadian InsAtutes of Health Research

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In today’s talk, we will review and interpret the best evidence for:

1.  RouAne chest PT with mechanically venAlated paAents

2.  Early rehabilitaAon and mobility in the ICU

What happens to patients after the ICU?

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ProspecAve 1 and 5-‐year follow-‐up study of 109 ICU survivors

Clinical Course

ICU Discharge ICU

Admission

SeUng: 4 Canadian ICUs PopulaAon: Adult paAents with ARDS

3 months 6 months 12 months

Outcomes: Primary – 6 minute walk test Pulmonary funcAon tests Health-‐related quality of life

60 months N=83 281 m 49% predicted

N=83 422 m 66% predicted

6 minute walk distance



Herridge et al, NEJM. 2003. 348:683-‐93;Herridge et al., NEJM. 2011. 364:1293-‐304.

ProspecAve 1 year study of 545 ICU survivors

Clinical Course

ICU Discharge ICU

Admission

6 months

Outcomes: Primary – SF-‐36 (V2) Physical funcAon domain Secondary – Physical, psychological, & cogniAve funcAon; quality of life; employment status

12 months

Needham et al., BMJ. 2013. 346:f1532.

SF-‐36 Physical FuncAon 82(9) 51(32) 55(32)

SF-‐36 Mental Health 76(3) 64(26) 65(25) “SubstanAal” PTSD 26% (122/514) 23% (107/487) Employed 52% (116/223) 52% (116/223)

Outcomes

Mean (SD) ICU LOS: 14(12); Hospital LOS: 22(16)

Norms

SeUng: 41 US ICUs PopulaAon: Adult pts with ARDS in NHLBI EDEN RCT

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CogniAve funcAon 3 and 12 months post-‐ICU Median ICU length of stay = 5 days

Pandharipande et al. N Engl J Med 2013;369:1306-16.

Normal

Mild cognitive impairment

Traumatic brain injury

Alzheimer’s disease

Needham et al., Crit Care Med. 2005. 33(3):574-‐9.

é40%

Projected incidence of non-‐cardiac surgery, mechanically venAlated adults

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ICU Rehab in Canada •  Canadian survey of ICU mobilizaAon pracAces

–  Rigorous survey of academic ICUs –  311 respondents (117 PTs, 194 MDs), 71% response –  68% rated early mobilizaAon “very important” or “crucial”

•  Reported PT pracAce: – Average 7.2 hours/ day – Average caseload 6 ICU + 10 ward paAents –  83% “frequently” or “rouAnely” provided chest PT – Aker 5:00 pm or on weekends, priority is chest PT, not mobility

Koo, KY. 2012. Open Access DissertaAons and Theses. Paper 7499.

We have a potenAally serious supply and demand problem in Canada:

Landry et al., Human Resources for Health 2007, 5:23.

1991 -‐ 2005

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What is the evidence for chest physiotherapy in paAents receiving

mechanical venAlaAon?

Terminology: What is chest physiotherapy?

posiAoning Manual hyperinflation

Ventilator hyperinflation

percussion vibration Rib cage compression

Airway clearance

techniques

suctioning

All are intervenAons to improve respiratory funcAon, which can be delivered by a registered physiotherapist or other

members of the criAcal care team.

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Systematic reviews use specific methods to limit bias and random error.

Ann Intern Med 1997;126:376-380.

Tip #1: How to use a systematic review

Oxman et al., JAMA. 1994. 272(17):1367-71.

Clinical Implications: •  Is it the right

question? •  If authors do a

meta-analysis, does combining these groups of patients make sense: •  Population •  Intervention •  Comparison

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Purpose: Ax effecAveness of PT intervenAons in MV paAents

PopulaAon: Adults >18 y

IntervenAon: MulAmodality Respiratory Physiotherapy

Comparison: Any (or none)

Outcomes: Any

Study designs: “relevant clinical arAcles”, systemaAc reviews, expert opinion papers, surveys

SAller. Chest. 2013. 144(3):825-‐47.

SAller. Chest. 2013. 144(3):825-‐47.

1. A priori design ✔2. Duplicate study selecAon &

extracAon ✖ 3. Comprehensive literature

search ✔ 4. Use of grey literature ✖ 5.  List of included and excluded

studies ✖ 6. CharacterisAcs of included

studies ✔

7.  Quality assessment of included studies ✖ (not GRADE)

8.  IncorporaAon of quality considered in analysis ✖

9.  Appropriate pooling? N/A 10. PublicaAon bias assessed N/A 11. Conflict of interest stated ✔

Methodological assessment (AMSTAR)

AMSTAR reference:

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SAller. Chest. 2013 Sep;144(3):825-‐47.

Results: MulAmodality respiratory physiotherapy •  18 clinical studies

–  5 randomized clinical trials –  9 randomized crossover trials –  1 systemaAcally allocated controlled trial –  1 historical controlled trial –  2 observaAonal studies

•  Of the 5 RCTs –  excluded pts w/ pleural effusions, untreated pneumothorax, neuromuscular weakness

Author PopulaAon IntervenAon Comparison Main Outcomes

Patman et al., 2001 / Australia

Post-‐op cardiac surgery MV <24h

PosiAoning, MH, thoracic & arm exs (n=101)

No PT during intubaAon (n=109)

# PT Rx while intubated; post-‐op pulmonary complicaAons


Acquired brain injury >24 h MV

Targeted posiAoning, MH 6x30min q24h unAl weaned (n=72)

General posiAoning, MH (n=72)

1°: VAP 2°: LOS, MV duraAon, mortality

Barker et al. 2002 / UK

Acute lung injury & MV

1: 1 Rx of posiAoning, 6 MH breaths, (n=7); 17 min

2: RouAne care (n=5); 5 min 3: PosiAoning (n=5); 15 min

OxygenaAon, dynamic compliance, & hemodynamics

MH = manual hyperinflaAon; VAP = venAlator-‐associated pneumonia; LOS = length of stay All groups received sucAoning

DescripAon of RCTs

SAller. Chest. 2013 Sep;144(3):825-‐47.

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Templeton et al., 2007 / UK

Med-‐Surg ICU >48 h MV

PosiAoning, MH, rib springing, mobility BID (n=87)*

PosiAoning, mobility BID (n=85)*

1°: Ame to venAlator free 2°: LOS, mortality, VAP

Paxanshexy et al. 2010 / India

ICU >48 h MV PosiAoning, MH, chest vibraAon BID unAl weaned (n=50)

MH BID unAl weaned (n=50)

1°: VAP 2°: LOS, mortality

Paxanshexy et al., 2011 / India NEW

ICU >48 h MV Same as above; (n=87)

Same as above; (n=86)

1°:“recovery rate” 2°: LOS, VAP

MH = manual hyperinflaAon; VAP = venAlator-‐associated pneumonia; LOS = length of stay All groups received sucAoning *allowed “rescue therapy” for sudden sustained desaturaAon due to mucous plugging

DescripAon of RCTs (cont’d)

SAller. Chest. 2013 Sep;144(3):825-‐47. Paxanshexy et al., Indian J Med Sci. 2011;65(5):175-‐185.

GRADE = Grades of RecommendaAon Assessment, Development and EvaluaAon

CMAJ 2003, BMJ 2004, BMC 2004, BMC 2005, AJRCCM 2006, Chest 2006, BMJ 2008

2 part framework: 1.  Quality of Evidence 2.  Strength of recommendations

“Extent to which we are confident that an es6mate of effect is correct.”

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GRADE Quality assessment criteria

Lower if…

Quality of evidence High Moderate Low Very low

Study limitations (design and execution) Inconsistency Indirectness Imprecision Publication bias

Observational studies

Study design Randomized trials

Higher if… Large effect (e.g., RR 0.5) Very large effect (e.g., RR 0.2) Evidence of dose-response

gradient All plausible confounding

would reduce a demonstrated effect

Slide from Schünemann/ Falck-‐Yxer

GRADE Quality Assessment (SAller et al.) Of 6 parallel group RCTs (n=816 paAents), •  Most evidence low to very low quality (⊕⊕⊝⊝) •  Reasons for downgrading

–  Imprecision (small sample sizes) –  Indirectness (differences in intervenAons) –  Inconsistent results –  Study design limitaAons

•  Outcomes assessors not blinded to group

•  Overall weaknesses in study reporAng GRADE InterpretaAon: Our confidence in the effect is limited: The true effect may be substanAally different from the esAmate of the effect.

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Author PopulaAon Main Outcomes (IntervenAon v. control) Templeton et al., 2007 / UK

All pts Med-‐Surg ICU >48 h MV

1°: Ame to venAlator free 4 d longer (median 15 vs. 11; p=0.045) 2°: LOS, mortality, VAP no difference

Paxanshexy et al. 2010 / India

All pts ICU >48 h MV

1°: VAP – no difference 2°: LOS – no difference, mortality lower (12/50 vs. 25/51, p=0.007)

Paxanshexy et al., 2011 / India NEW

All pts ICU >48 h MV

1°:“recovery rate” bexer 2°: hospital LOS 3.2 days longer (p=0.000), VAP no difference

MH = manual hyperinflaAon; VAP = venAlator-‐associated pneumonia; all groups received sucAoning

Results by paAent populaAon

Author PopulaAon Main Results Patman et al., 2001 / Australia

Post-‐op cardiac surgery MV <24h

No difference in duraAon of MV, ICU or hospital LOS


Acquired brain injury >24 h MV

1°: VAP – no difference 2°: LOS, MV duraAon, mortality -‐ no difference




MH = manual hyperinflaAon; VAP = venAlator-‐associated pneumonia; all groups received sucAoning

Results by paAent populaAon

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Outcome # studies Summary of Results DuraAon of mechanical venAlaAon

3 1 study, Ame to venAlator free 4 d longer in group receiving chest PT (median 15 vs. 11; p=0.045)

VenAlator-‐associated pneumonia

3 No difference

ICU LOS 2 No difference Hospital LOS 2 •  1 study, 3.2 days longer in group

receiving chest PT (p=0.000) •  1 study, no difference

Mortality 2 •  1 study, lower in group receiving chest PT (12/50 vs. 25/51, p=0.007)

•  1 study, no difference

RCTs of chest PT for paAents receiving mechanical venAlaAon

Purpose: Ax comparaAve studies of nonpharmaologic intervenAons to achieve mucus clearance

PopulaAon: Hospitalized or post-‐op pts without CF >1 year old

IntervenAon: Airway clearance techniques

Comparison: Any (or none)

Outcomes: Many, including MV, pulmonary funcAon, gas exchange, vital signs & symptoms, sputum clearance, harms, ICU/hospital LOS

Study designs: Controlled trials, observaAonal studies, including prospecAve cohort studies

Andrews et al., Respir Care. 2013. 58(12): 2160 -‐2186.

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1. A priori design ✔2. Duplicate study selecAon &

extracAon ✔3. Comprehensive literature

search ✔ 4. Use of grey literature ✖ 5.  List of included and excluded

studies ✔ 6. CharacterisAcs of included

studies ✔

7.  Quality assessment of included studies ✔

8.  IncorporaAon of quality considered in analysis ✔

9.  Appropriate pooling? N/A 10. PublicaAon bias assessed N/A 11. Conflict of interest stated ✔

Methodological assessment (AMSTAR)

AMSTAR reference:

Results: •  32 clinical studies

–  24 randomized clinical trials –  7 randomized crossover trials –  1 prospecAve cohort studies

•  Of the 24 RCTs –  6 adult intubated MV, 375 paAents


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1: 1 Rx of posiAoning, 6 MH breaths, (n=6); 17 min

2: RouAne care (n=6); 5 min 3: PosiAoning (n=6); 15 min


Ntoumenopoulos et al., 1998 / Australia

Trauma ICU MH, PD 20 min BID (n=22)

MH, PD only if new pneumonia (n=24)

Pulmonary funcAon, ICU LOS

Templeton et al. 2007 / UK

Med-‐Surg ICU >48 h MV

PosiAoning, MH, rib springing, mobility BID (n=87)*

PosiAoning, mobility BID (n=85)*

1°: Ame to venAlator free 2°: LOS, mortality, VAP

MH = manual hyperinflaAon; PD = postural drainage; VAP = venAlator-‐associated pneumonia; all groups received sucAoning *allowed “rescue therapy” for sudden sustained desaturaAon due to mucous plugging

IntervenAons including manual hyperinflaAon



Chen et al. 2009 / Taiwan

ICU >3d MV PosiAoning, chest vibraAon q 4h x 72h (n=50)

PosiAoning (n=45)

Sputum volume

Krause et al. 2000 / S. Africa

Acute lobar atelectasis

PD 15 min, percussion 5 min, BID (n=9)

Modified PD, percussion (n=8)

PaO2, SaO2

Unoki et al., 2005 / Japan

ICU >48h MV Chest compression + sucAon then sucAon alone (N=31)

SucAon alone then chest compression + sucAon (N=31)

Sputum, respiratory compliance, PaO2/FiO2, PaCO2

PD = postural drainage; all groups received sucAoning

Manual techniques


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GRADE Quality Assessment (Andrews et al.) Of 6 RCTs (n=375 paAents), •  Most evidence low to very low quality (⊕⊕⊝⊝) •  Reasons for downgrading

–  Imprecision (small sample sizes) –  Indirectness (differences in intervenAons) –  Inconsistent results –  Study design limitaAons

•  Outcomes assessors not blinded to group

•  Overall weaknesses in study reporAng GRADE InterpretaAon: Our confidence in the effect is limited: The true effect may be substanAally different from the esAmate of the effect.

Author PopulaAon Main Outcomes Barker et al. 2002 / UK Acute lung

injury & MV No difference: OxygenaAon, dynamic compliance, & hemodynamics

Ntoumenopoulos et al., 1998 / Australia

Trauma ICU No difference: pulmonary funcAon or ICU LOS

Templeton et al. 2007 / UK

Med-‐Surg ICU >48 h MV*

1°: Ame to venAlator free 4 d longer (median 15 vs. 11; p=0.045) 2°: LOS, mortality, VAP no difference

MH = manual hyperinflaAon; PD = postural drainage; VAP = venAlator-‐associated pneumonia; all groups received sucAoning *allowed “rescue therapy” for sudden sustained desaturaAon due to mucous plugging

Results: Manual hyperinflaAon

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Author PopulaAon Main Outcomes Chen et al. 2009 / Taiwan

ICU >3d MV No difference: Sputum volume

Krause et al. 2000 / S. Africa

Acute lobar atelectasis

No difference: PaO2, SaO2

Unoki et al., 2005 / Japan

ICU >48h MV No difference: Sputum, respiratory compliance, PaO2/FiO2, PaCO2

PD = postural drainage; all groups received sucAoning

Results: Manual techniques

Strengths and LimitaAons of Data Strengths ü Published clinical trials ü 2 published systemaAc reviews

ü UAlizaAon-‐focused outcomes

LimitaAons •  Applicability in Canadian seUng?

•  Need more focused study of specific populaAons / indicaAons

•  Need more detailed intervenAon reporAng –  Frequency, Intensity, Time, Type

•  Need more paAent-‐specific outcomes –  E.g., FuncAon

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WHAT IS THE EVIDENCE FOR EARLY MUSCLE WEAKNESS IN THE ICU?

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

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

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

~ day 7

Vivodtzev et al., CriAcal Care. 2014. 18:431.

3. PaAents 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

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Summary: Why is rehab in the ICU important? 1.  The 1st 10 days of bedrest are crucial:

–  Muscle strength losses –  Cardovascular decondiAoning

2.  ICU survivors experience important long-‐term physical and cogniAve dysfuncAon

3.  RehabilitaAon is essenAal to paAents’ recovery

Early ICU Rehab in Canada •  Canadian survey of ICU mobilizaAon pracAces

– Rigorous survey of academic ICUs – 311 respondents (117 PTs, 194 MDs), 71% response

•  Knowledge gap: – 69% of ICU clinicians underesAmated the incidence of ICU-‐acquired weakness

– 39% of PTs reported inadequate educa3on for ICU mobility

Koo, KY. 2012. Open Access DissertaAons and Theses. Paper 7499.

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WHEN SHOULD WE START TREATMENTS FOR MUSCLE WEAKNESS?

Barr et al. Crit Care Med. 2013. 41:263-‐306.

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

EffecAv

e Th

erap

ies

Ineff

ecAv

e Th

erap

ies

IntervenAons to improve physical funcAon post-‐ICU In-‐ICU Post-‐ICU Post-‐Hospital

IntervenAon Type: nExercise / Physical therapy; nNon-‐exercise X = measurement Ame point

Barriers to ICU rehabilitaAon? PotenAal Barrier Evidence Mechanical VenAlaAon No life-‐threatening adverse events1 Vasopressors/ Inotropes

Not a contraindicaAon to starAng early rehabilitaAon2

Dialysis Mobility may improve CRRT filter life3

Femoral catheter in situ No safety events4,5

SedaAon Sedated paAents can do some acAve cycling6

1Li et al., Arch PM & R. 2013. 94:551-‐61. 2Pohlman et al., Crit Care Med 2010; 38:2089–2094.

3Damluji et al., J Crit Care. 2013;28(4):535.e9-‐15. 4Perme et al. Cardiopulmonary Phys Ther Journal. 2013, 24(2), 12-‐17.

5Wang et al. CriAcal Care 2014, 18:R161. 6Kho et al., AJRCCM. 2014. 189. A3880.

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Of 1,110 paAents and 5,267 PT treatment sessions in MICU, adverse events were rare

No cardiorespiratory arrests, or removal of ETT or trach, dialysis/ pheresis catheters, or CVCs.

Sricharoenchai et al. Journal of CriAcal Care. 2014. 29:395–400.

Overall Event Rate = 0 to 1.9 events per 1,000 PT sessions

Incident ICU Admission

| BurAn et al., 2009

| Chiang et al., 2006 (Quasi RCT) | Porta et al., 2005

| Nava et al., 1998

Li et al., Archives of Physical Medicine and RehabilitaAon. 2013. 94:551-‐61).

Adult paAents mechanically venAlated > 24 h IniAaAon of AcAve MobilizaAon intervenAon; All RCTs unless specified

2 Weeks 4 Weeks >4 Weeks

| Schweickert et al., 2009 | Morris et al., 2007 (ProspecAve cohort)

| Chen et al., 2011 | Chen et al., 2012

Orange = Resp ICU Blue = Medical ICU Blue / Red = Med Surg ICU

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Primary Outcome: Independent funcAonal status @ hospital discharge (6 ADLs + independent walking)

R

Daily interrupAon of sedaAon + Early OT/PT 7d/wk N=49

Daily interrupAon of sedaAon + Standard care OT/PT N=55

Medical ICU

N=104

59% (29/49)

35% (19/55)

p=0.02

Schweickert et al., Lancet. 2009. 373: 1874-‐82.

It’s about receiving therapy while on mechanical venAlaAon IntervenAon PROM -‐> AAROM -‐> AROM -‐> Bed Mobility -‐> Transfers (siUng) -‐> SiUng balance -‐> ADLs -‐> Transfers (standing) -‐> AmbulaAon

IntervenAon N=49

Control N=55

Median Ame to start therapy (d) 1.5 [1.0 to 2.1]* 7.4 [6.0 to 10.9]

Median duraAon of therapy (h/d) During MV 0.32 [0.17 to 0.48]* 0 [0 to 0]

During no MV 0.21 [0.08 to 0.33] 0.19 [0 to 0.38]

*= p<0.01 0.32 h/d = 19.2 minutes

Schweickert et al., Lancet. 2009. 373: 1874-‐82.

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Primary Outcome: Tower Test 3 months post-‐ICU

10.0 [8.0-‐11.0] N=18

10.0 [8.8-‐12.0] N=12

Single center Medical (n=53) Surgical (n=34)

Brummel et al., Intensive Care Med. 2014. 40(3):370-‐9.

CogniAve Therapy + Early PT N=43

Usual Care N=22

R N=87

Early PT N=22

11.0 [11.0-‐12.0] N=14

p=0.20

Normal = 7 to 13 Higher scores = bexer

Primary Outcome: 6 minute walk test @ 12 months (model esAmates)

R

Intensive exercise in ICU, on ward, and post-‐ICU N=74

Standard care N=76

Medical/ Surgical ICU

N=150

409.6 (22.9) m N=41

404.9 (23.0) m N=38

p=0.884

Denehy et al. Crit Care. 2013, 17:R156.

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RCT of cycling in the ICU

Treatment (5d/wk) • Cycling OD 20 min; passive/ acAve

• Respiratory PT • A/PROM U+L/E • AmbulaAon as appropriate N=45; median Ame to Rx: 14d

Control (5d/wk) • Respiratory PT • A/PROM U+L/E • AmbulaAon as appropriate N=45; median Ame to Rx: 10d

R N=90

Primary outcome 6 minute walk distance @ hospital discharge (∆=50 m)

196 m [126-‐329m] N=26

143 m [37-‐226m] N=32

p<0.05

Single center Medical (n=19) Surgical (n=71)

BurAn et al., Crit Care Med. 2009. 37(9): 2499-‐2505.

Criteria

Schweickert et al. (early rehab)

BurAn et al. (cycling)

RandomizaAon ü ü AllocaAon concealment ü ü Blinding – caregivers û û Blinding – outcome assessors ü Not reported

Analysis by paAents randomized ü ü Enrolled paAents contribuAng to primary outcome analysis

100% (23 died -‐ scores of 0)

64% (32 died)

CointervenAons No imbalances Rx gp: ↑sedaAon, ↑NMBs

ContaminaAon none none

Methodological CriAcal Appraisal

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4. Ensure all paAents receive the intervenAons: Evaluate – ICU LOS

Lord et al. Crit Care Med. 2013 Mar;41(3):717-‐24.

4. Ensure all paAents receive the intervenAons: Evaluate – Hospital LOS

Lord et al. Crit Care Med. 2013 Mar;41(3):717-‐24.

Projected Net Cost savings for 900 admissions/ yr: $817,836 •  22% reducAon in ICU LOS •  19% reducAon in floor LOS

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Summary of the state of the science: Mobility

Strengths •  IntervenAons started within 1st week of ICU

•  Use of pilot trials to inform future research

•  ConAnuum of intervenAons

•  Methodological rigor

Future consideraAons •  IntervenAon feasibility

–  Recruitment –  Delivery (Ame req’d) –  Reproducibility

•  Common outcome measures

•  PaAent-‐important outcomes •  Longer follow up post-‐ICU

PracAcal consideraAons

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Based on best available evidence:

Supply: •  Projected future shortage of PTs •  PT availability ~7 h/ day

Demand: •  Increased demand for MV •  More ICU survivors at risk for

post-‐ICU sequelae

Q: Should we offer rouAne chest physiotherapy for all MV paAents? A: No Q: Do we sAll need chest physiotherapy in the ICU? A: It depends…. Q: Should we abandon study of chest physiotherapy in the ICU? A: No – field ripe for research in specific populaAons / indicaAons; ideal for interdisciplinary teams

What are the opportunity costs with limited resources and increased demands?

Summary of best evidence 1.  RouAne chest PT with mechanically

venAlated paAents –  Small studies, varied intervenAons, mainly body

structure / funcAon outcomes –  Role of “rescue therapy” for sudden sustained

desaturaAon due to mucous plugging? 2.  Early rehabilitaAon and mobility in the ICU

–  Addressing effects of bed rest – physical, cogniAve, mental health impacts

–  Effects on paAent funcAon at hospital discharge –  Need long term outcome data

[email protected]

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