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The Emergency Department Sedation Pilot Trial (ED SED Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410783
Recruitment Status : Not yet recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Collaborators:
University of Iowa
Cooper University Health Care
Information provided by (Responsible Party):
Brian Fuller, Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Respiratory Failure Behavioral: Education Other: Standard post intubation sedation practices Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a prospective, before-and-after study, and there will be no randomization process.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
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

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.




Primary Outcome Measures :
  1. Participant recruitment [ Time Frame: Through study completion, an average of 1 year ]
    Count of eligible participants included in study

  2. Proportion of Richmond Agitation-Sedation Scale (RASS) scores in deep sedation range [ Time Frame: Up to 12 hours (during mechanical ventilation in the emergency department) ]

    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


  3. Reliability of Richmond Agitation-Sedation Scale (RASS) measurements during routine care in the ED [ Time Frame: Up to 12 hours (during mechanical ventilation in the emergency department) ]
    Interrater correlation coeficient

  4. Adverse Events [ Time Frame: Up to 12 hours (during mechanical ventilation in the emergency department) ]
    Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events


Secondary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: Up to 28 days ]
    Ventilator-free days

  2. Duration of stay in ICU [ Time Frame: Up to 28 days ]
    ICU-free days

  3. Duration of stay in hospital [ Time Frame: Up to 28 days ]
    Hospital-free days

  4. Incidence of acute brain dysfunction (delirium + coma) [ Time Frame: Up to 7 days ]

    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.


  5. Mortality [ Time Frame: Up to 28 days, or for the duration of hospitalization ]
    Hospital mortality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410783


Contacts
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Contact: Brian Fuller, MD 314 747-5368 fullerb@wustl.edu

Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Contact: Nicholas Mohr, MD       nicholas.mohr@uiowa.edu   
United States, New Jersey
Cooper University Hospital/Cooper Medical School of Rowan University
Camden, New Jersey, United States, 08103
Contact: Brian Roberts, MD       roberts-brian-w@cooperhealth.edu   
Sponsors and Collaborators
Washington University School of Medicine
University of Iowa
Cooper University Health Care
Investigators
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Principal Investigator: Brian Fuller, MD Washington University School of Medicine
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Responsible Party: Brian Fuller, Associate Professor of Anesthesiology and Emergency Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04410783    
Other Study ID Numbers: 201909100
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Fuller, Washington University School of Medicine:
Sedation
Mechanical Ventilation
Emergency Department
RASS
Additional relevant MeSH terms:
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Respiratory Insufficiency
Emergencies
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases