The Emergency Department Sedation Pilot Trial (ED SED Pilot)

The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department

The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated emergency department patients at three academic medical centers: Washington University in St. Louis School of Medicine (St. Louis, MO), Cooper Hospital of Rowan University (Camden, NJ), and University of Iowa Carver College of Medicine (Iowa City, IA). The overall goal is to assess the feasibility of implementing targeted sedation (in terms of sedation depth) for mechanically ventilated ED patients in order to reduce the incidence of unnecessary deep sedation and improve clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Mechanical Ventilation
• Intervention / Treatment: Other: Standard post intubation sedation practices; Behavioral: Education

Detailed Description

The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated ED patients at three academic medical centers. Patients in the before phase of the study will receive usual care after the initiation of mechanical ventilation. After 172 patients have been enrolled in the before phase, the investigators will begin educational initiatives to implement ED-based sedation protocols and order sets. The research team will educate providers on the importance of sedation protocols on patient outcome so that the existing protocols begin to be used effectively in the ED. This educational initiative will allow targeted sedation to be effectively used in the ED as well, allowing the intervention to be tested under real-world conditions. Participants in the after phase will also receive standard post-intubation care at the discretion of the treating team, though it will be after the educational initiative aimed at improving post-intubation sedation.

In order to more effectively use sedation in the ED, the investigators will collect voluntary and anonymous surveys from ED nurses and physicians to assess the potential facilitators and barriers to adherence to guideline-recommended sedation.

• Study Type: Interventional
• Enrollment (Actual): 415
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine/Barnes-Jewish Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital/Cooper Medical School of Rowan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Mechanical ventilation via an endotracheal tube.
2. Age ≥ 18 years.

Exclusion Criteria:

1. Acute neurologic injury (stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, status epilepticus, fulminant hepatic failure).
2. Ongoing neuromuscular blockade.
3. Death or transition to comfort measures within 24 hours.
4. Transfer to another hospital from the ED.
5. Chronic/home mechanical ventilation.
6. Transfer directly from the ED to the operating room.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Before group; Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation	Other: Standard post intubation sedation practices; Usual care sedation provide in the ED
Other: After group; Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED	Behavioral: Education; Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant recruitment	Count of eligible participants included in study	Through study completion, an average of 1 year
Proportion of Richmond Agitation-Sedation Scale (RASS) scores in deep sedation range	Deep sedation defined as RASS of -3 to -5 Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable	Up to 12 hours (during mechanical ventilation in the emergency department)
Reliability of Richmond Agitation-Sedation Scale (RASS) measurements during routine care in the ED	Interrater correlation coeficient	Up to 12 hours (during mechanical ventilation in the emergency department)
Adverse Events	Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events	Up to 12 hours (during mechanical ventilation in the emergency department)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	Ventilator-free days	Up to 28 days
Duration of stay in ICU	ICU-free days	Up to 28 days
Duration of stay in hospital	Hospital-free days	Up to 28 days
Incidence of acute brain dysfunction (delirium + coma)	Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care. Coma defined as having as depth of sedation measurements (RASS) in the deep sedation range.	Up to 7 days
Mortality	Hospital mortality	Up to 28 days, or for the duration of hospitalization

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Iowa; Cooper University Health Care
• Investigators: Principal Investigator: Brian Fuller, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Fuller BM, Pappal RD, Mohr NM, Roberts BW, Faine B, Yeary J, Sewatsky T, Johnson NJ, Driver BE, Ablordeppey E, Drewry AM, Wessman BT, Yan Y, Kollef MH, Carpenter CR, Avidan MS. Awareness With Paralysis Among Critically Ill Emergency Department Patients: A Prospective Cohort Study. Crit Care Med. 2022 Oct 1;50(10):1449-1460. doi: 10.1097/CCM.0000000000005626. Epub 2022 Jul 21.
• Fuller BM, Roberts BW, Mohr NM, Pappal RD, Stephens RJ, Yan Y, Carpenter C, Kollef MH, Avidan MS. A study protocol for a multicentre, prospective, before-and-after trial evaluating the feasibility of implementing targeted SEDation after initiation of mechanical ventilation in the emergency department (The ED-SED Pilot Trial). BMJ Open. 2020 Dec 16;10(12):e041987. doi: 10.1136/bmjopen-2020-041987.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): August 2, 2021
• Study Completion (Actual): September 12, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Emergency Department; Sedation; Mechanical Ventilation; RASS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Emergencies; Respiratory Insufficiency
• Other Study ID Numbers: 201909100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Sharing of data generated by this trial is an important part of the proposed activities. Data will be shared with other investigators through academically established means, as necessary and appropriate. Datasets generated from the trial will be available from the overall study principal investigator on reasonable request. Collaboration with others investigators is encouraged. The results will be disseminated via publication in a peer-reviewed journal and presentation at national meetings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No