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Richard Appleton MBChB, FRCA

Richard Appleton MBChB, FRCA. SCCTG, E-BMG & SICSAG Annual Conference. Background. Critical illness is associated with subsequent weakness, protracted rehabilitation, disability and impaired quality of life Early rehabilitation Sedation breaks

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Richard Appleton MBChB, FRCA

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  1. Richard AppletonMBChB, FRCA SCCTG, E-BMG & SICSAG Annual Conference

  2. Background • Critical illness is associated with subsequent weakness, protracted rehabilitation, disability and impaired quality of life • Early rehabilitation • Sedation breaks • Delirium in ICU is common and adversely influences ICU outcomes

  3. Hypothesis Combination of daily interruption of sedation with physical and occupational therapy would affect both functional and neuropsychiatric outcomes

  4. Methods - Patients • 2 medical ICUs in USA • Within 72 hours of ICU admission • Previously independent • Exclusions • Rapidly developing neuromuscular disease • Cardiopulmonary arrest • Irreversible disorders with 6-month mortality greater than 50% • Raised ICP • Absent limbs • Enrolment in another study

  5. Methods - Interventions • Both groups received sedation breaks as per original Kress study • Intervention group: • Progressive exercise and mobilisation activities within safety criteria • Participation in activities of daily living (ADLs) • Control group: standard care • Daily rehabilitation therapy continued after ICU discharge until patient reached previous level of functioning • ICU care otherwise as standard for institutions

  6. Methods - Outcomes • Primary: • Number of patients reaching independent functional status at hospital discharge • Secondary: • Lengths of stay, duration of mechanical ventilation • Hospital days with delirium • Range of functional and strength measurement outcomes at hospital discharge

  7. Methods • Allocation concealment • Consecutively numbered sealed, opaque envelopes • Randomisation • Computer generated • Restricted randomisation • Permuted block design with 1:1 randomisation • Blinding • Patients, clinicians, physiotherapists/occupational therapists providing rehab all unblinded • Assessment therapists - blinded

  8. Statistics • Powering • Observational study that 50% of critically ill respiratory failure reached functional independence at hospital discharge • 30% difference in number of patients achieving return of independent functional status • Alpha of 0.05, beta of 0.2, two-sided significance • Sample size of 100 patients in total • Tests • Chi-squared, fisher’s exact for nominal data • Mann-Whitney for ordinal and non-normally distributed continuous data • T-tests for normally distributed continuous data • Time to event analysis • Kaplan-Meier • Log rank • Cox regression and proportional hazards

  9. Participant flow

  10. Baseline characteristics

  11. Care characteristics

  12. Results

  13. Results – what did they actually receive? Intervention group: • 46/49 (94%) received any physical and occupational therapy • Therapy occurred on 87% of days of study • Median duration of therapy whilst receiving mechanical ventilation: 0.32 hours/day (IQR 0.17-0.48) • Median duration of therapy whilst not receiving mechanical ventilation was 0.21 hours/day (IQR 0.08-0.33) • Therapy started a median of 1.5 days (IQR 1-2.1) after intubation

  14. Results – What did they actually receive? Control group: • Median duration of therapy whilst on mechanical ventilation: 0.0 hours/day (IQR 0-0, p<0.0001) • Median duration of therapy whilst not receiving mechanical ventilation was 0.19 hours/day (IQR 0.0-0.38, p=0.7) • Therapy started at a median of 7.4 days (IQR 6-10.9, p<0.0001), NB median ICU LOS 7.9 days

  15. Results – Time to achieve outcomes

  16. Key CAT questions Do statistical tests correctly test the results to allow differentiation of statistically significant results? • Limited multivariate analysis that did not take into account important baseline confounders Are conclusions valid in light of results? • The improvement in functional outcome, delirium and duration of mechanical ventilation may reflect: • the study intervention or • the natural history of the presenting illness, ? type 1 error

  17. Key CAT question? What level of evidence does this study represent? • 1- (RCT with high risk of bias) What grade of recommendation can I make when this study is considered along with other available evidence? • B

  18. Take home messages Early physical and occupational therapy may improve functional outcome at hospital discharge Though a larger, multi-centre study is required

  19. Any questions?

  20. Thank you!

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