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  • Canadian Critical Care Trials Group
    The Canadian Critical Care Trials Group (CCCTG) is a national organization of more than 300 individuals with research interests in the management of the critically ill patient.
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Principal Investigator(s)


Lisa Burry




Results of the SLEAP Trial: For mechanically ventilated adults managed with protocolized sedation, the addition of daily sedation interruption did not reduce the duration of mechanical ventilation or ICU stay.

The SLEAP Trial

Daily Sedation Interruption in Mechanically Ventilated Critically Ill Patients Cared for With a Sedation Protocol: A Randomized Controlled Trial

Lay Abstract

All critically ill, mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety. However, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the ICU. Two strategies have been shown to improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. We hypothesized that combining these strategies would augment patient benefits.

SLEAP was a multicenter trial conducted in 16 medical and surgical ICUs in Canada and the United States between January 2008 and July 2011. 430 critically ill patients on a breathing machine who were receiving analgesic (opioid) and/or sedating (benzodiazepine) medications continuously into their veins were randomly allocated to nurse-directed protocolized sedation (n=209) or to protocolized sedation plus daily sedation interruption (n=214). Using a sedation scale nurses adjusted the medications hourly to achieve light sedation. For patients receiving daily interruption, nurses resumed infusions, if indicated, at half of previous doses.

We found that patients in both groups spent a similar number of days on the breathing machine, and the same number of days in the ICU and the hospital. Patients managed with daily interruption received higher doses of pain and sedating medications; and nurse workload was greater in this group. There was no difference in the unintentional removal of medical devices between the two groups.

In conclusion, for mechanically ventilated adults who were managed with a nurse-directed sedation protocol, the addition of daily sedation interruption did not reduce time on the breathing machine or days in the ICU. The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere.

Trial Registration clinicaltrials.gov Identifier: NCT00675363


  1. Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, and Meade M, for the SLEAP Investigators and the Canadian Critical Care Trials Group. A randomized trial of daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol. JAMA 2012, published online October 17, 2012.
  2. Mehta S, Burry L, Martinez-Motta JC, Stewart TE, Hallett D, McDonald E, Clarke F, MacDonald R, Granton J, Matte A, Wong C, Suri A, Cook DJ, for the Canadian Critical Care Trials Group. A randomized trial of daily awakening in critically ill patients managed with a sedation protocol – A pilot trial. Crit Care Med 2008;36(7):2092-2099.
  3. Ethier C, Burry L, Martinez-Motta C, Tirgari S, Jiang D, McDonald E, Granton J, Cook D, Mehta S, for the Canadian Critical Care Trials Group. Recall of ICU stay in patients managed with a Sedation Protocol or a Sedation Protocol with Daily Sedative Interruption: A Pilot Study. J of Crit Care 2011;26:127-132. Epub Oct 1, 2010.