• Sangeeta Mehta, Lisa Burry, J Carlos Martinez-Motta, Thomas E Stewart, David Hallett, Ellen McDonald, France Clarke, Rod Macdonald, John Granton, Andrea Matte, Cindy Wong, Amit Suri, Deborah J Cook, and Canadian Critical Care Trials Group.
• Inter Departmental Division of Critical Care Medicine, Mount Sinai Hospital, University Health Network, and University of Toronto, Toronto, Ontario, Canada. geeta.mehta@utoronto.ca
• Crit. Care Med. 2008 Jul 1;36(7):2092-9.

ObjectiveProtocolized sedation (PS) and daily sedative interruption (DI) in critically ill patients have both been shown to shorten the durations of mechanical ventilation (MV) and intensive care unit (ICU) stay. Our objective was to determine the safety and feasibility of a randomized trial to determine whether adults managed with both PS + DI have a shorter duration of MV than patients managed with PS alone.DesignProspective randomized, concealed, unblinded, multicenter, pilot trial.SettingThree university-affiliated medical-surgical ICUs.PatientsSixty-five adults anticipated to require MV >48 hrs and receiving sedative/analgesic infusions.InterventionsPatients were randomized to PS alone, or PS + DI. PS was implemented by bedside nurses; sedatives/analgesics were titrated to achieve Sedation Agitation Score (SAS) 3-4. The PS + DI group also had infusions interrupted daily until the patients awoke.Measurements And Main ResultsDiagnosis, age [mean +/- SD] (53 +/- 18.3 vs. 62.1 +/- 16.7 yrs) and Acute Physiology and Chronic Health Evaluation II (27.7 +/- 8.4 vs. 26.6 +/- 8.4) were similar in the PS and PS + DI groups, respectively. The median duration of MV in the PS and PS + DI groups was 8.0 vs. 10.5 days, and ICU stay was 10.0 vs. 13.0 days, respectively. The SAS was within target range (3-4) in 59% of 9,611 measurements, and within an acceptable range (2-5) in 86% of measurements. Self-assessed nursing and respiratory therapist workload was low in the majority of the cohort. Adverse events were similar in both groups. Patient recruitment was slower than projected (1.5 patients/mo).ConclusionThis pilot trial comparing PS vs. PS + DI confirmed the safety and acceptability of the sedation protocol and DI, and guided important modifications to the protocol, thus enhancing the feasibility of a future multicenter trial. This trial was not designed to detect small but significant differences in clinically important outcomes.

25 keywords...

hide…