Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial
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Posted By: Elizabeth Sweetman
Posted Date: 13/09/08
Title: Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial
Authors: Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP.
Reference: Lancet. 2009 May 30;373(9678):1824-6.
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: BACKGROUND: Long-term complications of critical illness include intensive care unit (ICU)-acquired weakness and neuropsychiatric disease. Immobilisation secondary to sedation might potentiate these problems. We assessed the efficacy of combining daily interruption of sedation with physical and occupational therapy on functional outcomes in patients receiving mechanical ventilation in intensive care.
METHODS: Sedated adults (>/=18 years of age) in the ICU who had been on mechanical ventilation for less than 72 h, were expected to continue for at least 24 h, and who met criteria for baseline functional independence were eligible for enrolment in this randomised controlled trial at two university hospitals. We randomly assigned 104 patients by computer-generated, permuted block randomisation to early exercise and mobilisation (physical and occupational therapy) during periods of daily interruption of sedation (intervention; n=49) or to daily interruption of sedation with therapy as ordered by the primary care team (control; n=55). The primary endpoint-the number of patients returning to independent functional status at hospital discharge-was defined as the ability to perform six activities of daily living and the ability to walk independently. Therapists who undertook patient assessments were blinded to treatment assignment. Secondary endpoints included duration of delirium and ventilator-free days during the first 28 days of hospital stay. Analysis was by intention to treat. This trial is registered with, number NCT00322010.
FINDINGS: All 104 patients were included in the analysis. Return to independent functional status at hospital discharge occurred in 29 (59%) patients in the intervention group compared with 19 (35%) patients in the control group (p=0.02; odds ratio 2.7 [95% CI 1.2-6.1]). Patients in the intervention group had shorter duration of delirium (median 2.0 days, IQR 0.0-6.0 vs 4.0 days, 2.0-8.0; p=0.02), and more ventilator-free days (23.5 days, 7.4-25.6 vs 21.1 days, 0.0-23.8; p=0.05) during the 28-day follow-up period than did controls. There was one serious adverse event in 498 therapy sessions (desaturation less than 80%). Discontinuation of therapy as a result of patient instability occurred in 19 (4%) of all sessions, most commonly for perceived patient-ventilator asynchrony.
INTERPRETATION: A strategy for whole-body rehabilitation-consisting of interruption of sedation and physical and occupational therapy in the earliest days of critical illness-was safe and well tolerated, and resulted in better functional outcomes at hospital discharge, a shorter duration of delirium, and more ventilator-free days compared with standard care.
Are the Results Valid?
1. Was the assignment of patients to treatments randomized? ( Was allocation concealment maintained?)
Yes patients were randomly assigned to study groups using a computer-generated, permuted block randomization scheme.
Allocation concealment was maintained ; each assignment was designated in a consecutively numbered, sealed, opaque envelope by an investigator with no further involvement in the trial.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?
2a. Was followup complete?
Yes all 104 patients (Intervention Group n = 49 ; Control Group n = 55) randomized into trial were included in analysis according to the intention to treat.
2b. Were patients analyzed in the groups to which they were randomized?
Yes patients were analysed in the groups to which they were randomized.
3. Were patients, health workers, and study personnel blind to treatment?
The physical and occupational therapists assessing trial patients for the primary endpoint “return of independent functional status of patients at hospital discharge”, were blinded to patient assignment.
4. Were the groups similar at the start of the trial?
Yes patient groups were similar at the start of the trial (see Table 1, pg. 1876)
5. Aside from the experimental intervention, were the groups treated equally?
Yes the groups were treated equally.
What are the Results?
1. How large was the treatment effect?
Primary End point:
  • Return to Independent Functional Status at hospital discharge Intervention Group 29/49 (59%) vs Control Group 19/55 (35%) p = 0.02

    Secondary End points:
    1. Number of hospital days with delirium: ICU delirium:
    Intervention Group (Days) 2.0 (Range 0.0 – 6.0) vs Control Group (Days) 4.0 (Range 2.0 – 7.0) p = 0.03

    Hospital delirium:
    Intervention Group (Days) 2.0 (Range 0.0 – 6.0) vs Control Group (Days) 4.0 (Range 2.0 – 8.0) p = 0.02

    2. Ventilator-free days during first 28 days of hospital stay (days):
    Intervention Group 23.5 (Range 7.4 – 25.6) vs Control Group 21.1 (Range 0.0 – 23.8) p = 0.05

    3. Length of Stay in the ICU (days):
    Intervention Group 5.9 (Range 4.5 – 13.2) vs Control Group 7.9 (Range 6.1 – 12.9) p = 0.08

    4. Length of Stay in hospital (days):
    Intervention Group 13.5 (Range 8.0 – 23.1) vs Control Group 12.9 (Range 8.9 – 19.8) p = 0.93

    5. Hospital Mortality:
    Intervention Group 9/49 (18%) vs Control Group 14/55 (25%) p = 0.53

    End points at hospital discharge:
    1. Barthel Index Score at hospital discharge:
    Intervention Group 75 (Range 7.5 – 95) vs Control Group 55 (Range 0-85) p = 0.05

    2. Number of functionally independent ADLs at hospital discharge:
    Intervention Group 6 (Range 0 – 6) vs Control Group 4 (Range 0-6) p = 0.06

    3. Distance walked without assistance at hospital discharge (metres)
    Intervention Group 33.4 (Range 0 – 91.4) vs Control Group 0 (Range 0-30.4) p = 0.004

    4. Number of patients diagnosed with ICU acquired paresis at hospital discharge:
    Intervention Group 15/49 (31%) vs Control Group 27/55 (49%) p = 0.09

    5. Hand grip strength scoring at hospital discharge (kg-force):
    Intervention Group 39 (Range 10 – 58) vs Control Group 35 (Range 0 – 57) p = 0.67

  • 2. How precise was the estimate of the treatment effect?
    The authors in this paper did not report confidence intervals.
    We calculated the 95% CI around the primary outcome. It ranges between 6% benefit to 43% benefit.
    Will the Results Help Me In Caring For My Patients?
    1. Can the results be applied to my patient care?
    Yes. The patients in the trial are representative of the patients that you will see in our ICU. The intervention is relatively easy to conduct.
    2. Were all clinically important outcomes considered?
    Yes all clinically important outcomes were considered.
    This paper could have possibly considered an assessment of workload and costs and possibly longer term outcomes i.e. 6 mths, 12 mths post hospital discharge.
    3. Are the likely treatment benefits worth the potential harms and costs?
    No harm was documented in this trial.
    The intervention is likely to be relatively cheap compared to other interventions, and, patients probably highly value being functionally independent at hospital discharge.

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