Research

Randomized trial comparing daily interruption of sedation and nursing-implemented sedation algorithm in medical intensive care unit patients

Marjolein de Wit¹ , Chris Gennings² , Wendy I Jenvey¹ and Scott K Epstein³

¹Pulmonary and Critical Care Division, Department of Internal Medicine, School of Medicine, Virginia Commonwealth University, PO Box 980050, Richmond, VA 23298-0050, USA

²Department of Biostatistics, School of Medicine, Virginia Commonwealth University, Box 980032, Richmond, VA, USA

³Tufts University School of Medicine, 145 Harrison Street, Boston, MA 02111, USA

author email corresponding author email

Critical Care 2008, 12:R70doi:10.1186/cc6908

Published:	20 May 2008

Abstract

Introduction

Daily interruption of sedation (DIS) and sedation algorithms (SAs) have been shown to decrease mechanical ventilation (MV) duration. We conducted a randomized study comparing these strategies.

Methods

Mechanically ventilated adults 18 years old or older in the medical intensive care unit (ICU) were randomly assigned to DIS or SA. Exclusion criteria were severe neurocognitive dysfunction, administration of neuromuscular blockers, and tracheostomy. Study endpoints were total MV duration and 28-day ventilator-free survival.

Results

The study was terminated prematurely after 74 patients were enrolled (DIS 36 and SA 38). The two groups had similar age, gender, racial distribution, Acute Physiology and Chronic Health Evaluation II score, and reason for MV. The Data Safety Monitoring Board convened after DIS patients were found to have higher hospital mortality; however, no causal connection between DIS and increased mortality was identified. Interim analysis demonstrated a significant difference in primary endpoint, and study termination was recommended. The DIS group had longer total duration of MV (median 6.7 versus 3.9 days; P = 0.0003), slower improvement of Sequential Organ Failure Assessment over time (0.70 versus 0.23 units per day; P = 0.025), longer ICU length of stay (15 versus 8 days; P < 0.0001), and longer hospital length of stay (23 versus 12 days; P = 0.01).

Conclusion

In our cohort of patients, the use of SA was associated with reduced duration of MV and lengths of stay compared with DIS. Based on these results, DIS may not be appropriate in all mechanically ventilated patients.

Trial registration

ClinicalTrials.gov NCT00205517.