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Multicenter randomized trial of sedation using daily wake-up calls, bispectral index or clinical sedation scores in a mixed medical–surgical ICU population

Introduction

Daily interruption of continuous infusions of sedatives (wake-up calls (WC)) has been found previously to promote more rapid withdrawal of ventilatory support in ICU patients. Bispectral index (BIS) monitoring has been reported to adequately describe the depth of sedation in critically ill patients. We compared the effectiveness and safety of both sedation strategies in a mixed medical–surgical ICU population.

Methods

Patients expected to need sedation for at least 1 day were randomly assigned to a WC strategy, sedation guided by BIS, or a control group. Clinical assessment of the sedation depth, the Ramsay score, was performed in all three groups. Primary outcome: ICU length of stay (LOS); secondary outcomes: duration of mechanical ventilation, accidental removal of indwelling devices, ICU readmission rate, hospital LOS, 90-day mortality, and stressful events (interview at ICU exit and after 3 months).

Results

In four ICUs, three academic and one teaching hospital, a total number of 617 patients was randomized; 205 to the WC strategy, 202 to sedation guided by BIS, and 210 to the control group. The study groups were well balanced according to baseline characteristics. Neither ICU LOS (median (IQR) 11 (6 to 21) (WC), 12 (7 to 23) (BIS), and 11 (6 to 24) days (control), P = 0.67) nor duration of mechanical ventilation (median 165 (0 to 581) (WC), 158 (3 to 590) (BIS), and 163 (5 to 385) hours control, P = 0.97) were different between groups. Accidental removal of indwelling devices was encountered 37 times (10 times in nine patients (WC), six times in five patients (BIS), and 21 times in 11 patients (control), P = 0.01). The ICU readmission rate, hospital LOS, and 90-day mortality were not different between groups. Interviews showed similar stress experiences.

Conclusion

Although a significant higher number of incidents with indwelling devices occurred in the control group, no additional differences between the three sedation regimens were revealed. Although current guidelines on ICU sedation have incorporated WC next to clinical sedation scales, the results from this larger study do not promote either WC or BIS in guiding sedation of ICU patients.

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Binnekade, J., Wilde, R., Slooter, A. et al. Multicenter randomized trial of sedation using daily wake-up calls, bispectral index or clinical sedation scores in a mixed medical–surgical ICU population. Crit Care 13, P396 (2009). https://doi.org/10.1186/cc7560

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Keywords

  • Clinical Sedation
  • Bispectral Index
  • Sedation Score
  • Sedation Scale
  • Daily Interruption