Protocol for a multicentre, prospective cohort study of practice patterns and clinical outcomes associated with emergency department sedation for mechanically ventilated patients: the ED-SED Study

INTRODUCTION: In mechanically ventilated patients, sedation strategies are a major determinant of outcome. The emergency department (ED) is the earliest exposure to mechanical ventilation for hundreds of thousands of patients annually in the USA. The one retrospective study that exists regarding ED sedation for mechanically ventilated patients showed a strong association between deep sedation in the ED and worse clinical outcomes. This finding suggests that the ED may be an optimal location to study the impact of early sedation on outcome, yet a lack of prospective studies represents a knowledge gap in this arena. This protocol describes a prospective observational study aimed at further characterising ED sedation practices and assessing the relationship between ED sedation and clinical outcomes. An association between ED sedation and clinical outcomes across multiple sites would suggest the need for changes in the current sedation strategies used in the ED, and provide evidence for future interventional studies in this field. METHODS AND ANALYSIS: This is a multicentre, prospective cohort study testing the hypothesis that deep sedation in the ED is associated with worse clinical outcomes. A cohort of over 300 mechanically ventilated ED patients will be included. The primary outcome is ventilator-free days, and secondary outcomes include hospital mortality, incidence of acute brain dysfunction and lengths of stay. Multivariable linear regression will test the hypothesis that deep sedation in the ED is associated with a decrease in ventilator-free days. ETHICS AND DISSEMINATION: Approval of the study by the Institutional Review Board (IRB) at each participating site has been obtained prior to data collection on the first patient. This work will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at scientific meetings and data sharing with other investigators through academically established means.