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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04410783
Other study ID # 201909100
Secondary ID R34HL150404
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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