The Emergency Department Sedation Pilot Trial

NCT04410783 | Completed Results DMC

• 2 other identifiers: 201909100R34HL150404
• Study Type: interventional
• Target: 1,771
• Locations: 1 country
• Sites: 3

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.

Conditions

Mechanical Ventilation; Respiratory Failure

Keywords

Sedation; Mechanical Ventilation; Emergency Department; RASS

Outcome Measures

Primary Outcomes (4)

• Participant Recruitment

  Count of eligible participants included in study

  Through study completion, an average of 1 year

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

  Up to 12 hours (during mechanical ventilation in the emergency department)

• Number of Participants With 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 Outcomes (5)

• Ventilator-free Days

  Up to 28 days

• ICU-free Days

  Up to 28 days

• Hospital-free Days

  Up to 28 days

• Number of Participants With Delirium

  Up to 7 days

• Mortality

  Up to 28 days, or for the duration of hospitalization

Study Arms (2)

Before group

OTHER

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

After group

OTHER

Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED

Behavioral: Education

Interventions

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.

After group

Standard post intubation sedation practices OTHER

Usual care sedation provide in the ED

Before group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Iowa: collaborator
• Cooper University Health Care: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Cooper University Hospital/Cooper Medical School of Rowan University

Camden, New Jersey, 08103, United States

Location

Related Publications (2)

• 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.

  PMID: 35866657 DERIVED

• 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.

  PMID: 33328261 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Emergencies

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Brian M Fuller
• Organization: Washington Univeristy

fullerb@wustl.edu

3147475368

Study Officials

• Brian Fuller, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Emergency Medicine

Model Details: This is a prospective, before-and-after study, and there will be no randomization process.

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 1, 2020
• Study Start: September 14, 2020
• Primary Completion: May 28, 2022
• Study Completion: May 28, 2022
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)