The Emergency Department Sedation Pilot Trial

Respiratory Failure Clinical Trial

— ED SED Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410783
• Other study ID #: 201909100
• Secondary ID: R34HL150404
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: May 28, 2022

Study information

• Verified date: December 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1771
• Est. completion date: May 28, 2022
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Mechanical Ventilation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Other:
• Standard post intubation sedation practices
Usual care sedation provide in the ED

Locations

Country	Name	City	State
United States	Cooper University Hospital/Cooper Medical School of Rowan University	Camden	New Jersey
United States	University of Iowa	Iowa City	Iowa
United States	Washington University School of Medicine/Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Cooper University Health Care, National Heart, Lung, and Blood Institute (NHLBI), University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Recruitment	Count of eligible participants included in study	Through study completion, an average of 1 year
Primary	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)
Primary	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)
Primary	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	Ventilator-free 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.	Up to 28 days
Secondary	ICU-free 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.	Up to 28 days
Secondary	Hospital-free 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.	Up to 28 days
Secondary	Number of Participants With Delirium	Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.	Up to 7 days
Secondary	Mortality	Hospital mortality	Up to 28 days, or for the duration of hospitalization