# The Feasibility of Implementing Light Sedation after Initiation of Mechanical Ventilation in the Emergency Department: the ED-SED Pilot Trial

> **NIH NIH R34** · WASHINGTON UNIVERSITY · 2020 · $333,266

## Abstract

PROJECT SUMMARY/ABSTRACT
Annually in the United States, approximately 250,000 patients require mechanical ventilation in the emergency
department (ED) and over 30% will die. The majority of survivors experience crippling long-term disability
including cognitive decline, psychological dysfunction, and lengthy rehabilitation. Recent data suggest that
exposure to deep sedation (i.e. unconsciousness or coma due to excessive sedative administration) after the
initiation of mechanical ventilation is associated with greater mechanical ventilation duration, lengths of stay,
and mortality. Deep sedation is extremely common while mechanical ventilation is provided in the ED;
however, no clinical study has tested if targeting light sedation in the immediate post-intubation period in the
ED improves outcome. Our hypothesis is that targeting a light sedation depth after the initiation of mechanical
ventilation in the ED is associated with improved clinical outcomes, including a reduced duration of mechanical
ventilation. To test this hypothesis, our team will capitalize on our extensive experience with initiating clinical
studies in the ED and continuing these intervention protocols into the intensive care unit (ICU), and will
propose a future multi-center, stepped-wedge, cluster randomized trial. The scientific literature and our
preliminary data provide the rationale for conducting a large-scale clinical trial.
However, several gaps currently prohibit proceeding. The feasibility of implementing an ED-based goal-
oriented sedation protocol is unknown in terms of: 1) recruitment; 2) efficacy in achieving target sedation; 3)
reliability of sedation measurements during routine care in the ED; 4) adverse events; and 5) barriers to
implementation. Therefore this proposal is for a multicenter (n= 3) prospective before-and-after protocol
implementation study examining the feasibility of a protocol which targets light sedation after intubation among
344 mechanically ventilated adult ED patients. These data will be supplemented with a qualitative assessment
of barriers to implementation (survey of nurses and physicians). Through the aims of this preparatory pilot
study, we will acquire the necessary and sufficient data, and demonstrate a clear organizational structure,
critical to complete the full-scale clinical trial. This project has the potential to completely change the clinical
practice of early sedation management, and improve survival and quality of life in patients suffering from acute
respiratory failure. Given the magnitude of death and disability experienced by mechanically ventilated ED
patients, even modest improvements would provide a major public health benefit.

## Key facts

- **NIH application ID:** 9872687
- **Project number:** 1R34HL150404-01
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Brian M Fuller
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $333,266
- **Award type:** 1
- **Project period:** 2020-02-01 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9872687

## Citation

> US National Institutes of Health, RePORTER application 9872687, The Feasibility of Implementing Light Sedation after Initiation of Mechanical Ventilation in the Emergency Department: the ED-SED Pilot Trial (1R34HL150404-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9872687. Licensed CC0.

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