The Emergency Department Sedation Pilot Trial (ED SED Pilot)

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The Washington University

Status

Completed

Conditions

Respiratory Failure
Mechanical Ventilation

Treatments

Other: Standard post intubation sedation practices
Behavioral: Education

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04410783
R34HL150404 (U.S. NIH Grant/Contract)
201909100

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,771 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,771 participants in 2 patient groups

Before group
Other group
Description:
Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation
Treatment:
Other: Standard post intubation sedation practices
After group
Other group
Description:
Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED
Treatment:
Behavioral: Education

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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