Clinical trial NCT04410783: The Emergency Department Sedation Pilot Trial
Official title: The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Respiratory Failure
Keywords: Sedation
Mechanical Ventilation
Emergency Department
RASS
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: Cooper University Health Care
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-06-01
Enrollment: 1771
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, before-and-after study, and there will be no randomization process.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Participant Recruitment
timeFrame: Through study completion, an average of 1 year
measure: Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
timeFrame: Up to 12 hours (during mechanical ventilation in the emergency department)
measure: Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED
timeFrame: Up to 12 hours (during mechanical ventilation in the emergency department)
measure: Number of Participants With Adverse Events
timeFrame: Up to 12 hours (during mechanical ventilation in the emergency department)
Secondary outcomes:
measure: Ventilator-free Days
timeFrame: Up to 28 days
measure: ICU-free Days
timeFrame: Up to 28 days
measure: Hospital-free Days
timeFrame: Up to 28 days
measure: Number of Participants With Delirium
timeFrame: Up to 7 days
measure: Mortality
timeFrame: Up to 28 days, or for the duration of hospitalization
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes-Jewish Hospital
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital/Cooper Medical School of Rowan University
state: New Jersey
Study officials:
affiliation: Washington University School of Medicine
name: Brian Fuller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.