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Completed

NCT Number: NCT04410783

The Emergency Department Sedation Pilot Trial

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.

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Key information

Conditions

Mechanical Ventilation Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mechanical ventilation via an endotracheal tube.
  • Age ≥ 18 years.

Exclusion criteria

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

Treatment and study plan

Education

Behavioral

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.

Standard post intubation sedation practices

Other

Usual care sedation provide in the ED

Primary outcomes

  1. Participant Recruitment

    Time frame: Through study completion, an average of 1 year

    Count of eligible participants included in study

  2. Percentage of Patients With 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. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.

  4. Number of Participants With 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 outcomes

  1. Ventilator-free Days

    Time frame: Up to 28 days

    To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days.

  2. ICU-free Days

    Time frame: Up to 28 days

    To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days.

  3. Hospital-free Days

    Time frame: Up to 28 days

    To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days.

  4. Number of Participants With Delirium

    Time frame: Up to 7 days

    Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.

  5. Mortality

    Time frame: Up to 28 days, or for the duration of hospitalization

    Hospital mortality

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Cooper University Health Care
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Iowa

Registry information

Official study title

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

Acronym: ED SED Pilot

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2020
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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