The ED-AWARENESS-2 Trial (ED-AWARENES II)

Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial

The investigators will screen all mechanically ventilated ED patients for study eligibility and will enroll all consecutive patients satisfying inclusion and exclusion criteria.

The study design is a pragmatic, multicenter, stepped wedge cluster randomized trial, enrolling at five sites over a 3-year period, divided into six time periods of six months. Prior to the study, each site will be randomized to their position within the design. One site will cross to the intervention period (i.e. succinylcholine as default neuromuscular blocker) every six months from the 2nd to 6th time period. Cluster order will be determined by computer-based randomization. To begin, each site will be exposed to control conditions; by the end of the study, each site will be exposed to intervention conditions.

Patients in the control phase will receive usual care, and this phase will be entirely observational. After six months, a site will enter a 2-month transition phase. In this phase, the investigators will implement the intervention, similar to how they have implemented other ED-based interventions for mechanically ventilated patients. The investigators will engage and educate ED clinicians on the importance of AWP prevention and the study objectives. The intervention framework relies on the use of "nudges", without restricting choice. The use of neuromuscular blockers (i.e. "paralytic" medications) is already part of routine care in the ED in order to facilitate endotracheal intubation and initiation of mechanical ventilation for patients with acute respiratory failure. The two most common neuromuscular blockers used in the ED are succinylcholine and rocuronium. The preliminary data show a strong association between rocuronium (a longer-acting neuromuscular blocker) use and AWP. Therefore, this study aims to improve care by educating caregivers on AWP and the use of the neuromuscular blockers, which are already routinely used, and studying that process in a rigorous fashion. The default neuromuscular blocker in the intervention phase will be succinylcholine. Succinylcholine will be the default over rocuronium because: 1) it has safely been the default neuromuscular blocker of choice in the ED for >40 years ; 2) its 5-minute duration of action greatly reduces AWP risk; 3) the preliminary data regarding an increased risk of AWP with rocuronium and 4) ED rocuronium use has increased despite no patient-centered studies showing benefit over succinylcholine. Passive alerts (i.e. graphics, pocket cards) will also be strategically placed in the ED, and active alerts will be used as reminders before every nursing shift (i.e. "the huddle"). After this transition phase, the site will begin the intervention phase, and patients will again receive clinician-directed care, just after the intervention.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Intubation Complication; Mechanical Ventilation; Awareness
• Intervention / Treatment: Other: Standard neuromuscular blocker practices; Behavioral: Education

• Study Type: Interventional
• Enrollment (Estimated): 3090
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Fuller, MD; Phone Number: 314-747*5368; Email: fullerb@wustl.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • Roy J. and Lucille A. Carver College of Medicine
      • Contact: Nicholas Mohr, MD, MS; Phone Number: 319-384-8285; Email: Nicholas-mohr@uiowa.edu
      • Contact: Brett Faine, PharmD, MS; Phone Number: 319-384-5228; Email: brett-faine@uiowa.edu
      • Principal Investigator: Nicholas M Mohr, MD, MS
      • Sub-Investigator: Brett Faine, Pharmd, MS
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Recruiting
      • Hennepin Healthcare
      • Contact: Brian E Driver, MD; Phone Number: 612-873-7448; Email: brian.driver@hcmed.org
      • Principal Investigator: Brian E Driver, MD
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Hospital/Cooper Medical School of Rowan University
      • Contact: Brian Roberts, MD, Msc; Phone Number: 856-342-2352; Email: roberts-brian-w@cooperhealth.edu
      • Principal Investigator: Brian W Roberts, MD
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington School of Medicine
      • Contact: Megan Fuentes, BS; Phone Number: 206-744-5888; Email: mrf2@uw.edu
      • Principal Investigator: Nicholas J Johnson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Mechanical ventilation via an endotracheal tube
2. Age ≥ 18 years
3. Treatment with a neuromuscular blocker (for endotracheal intubation or during the post-intubation phase of care)

Exclusion Criteria:

1. Acute or chronic neurologic injury with deficit that prevents assessment of AWP (i.e. stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, severe dementia)
2. Death before extubation
3. Transfer to another hospital from the ED

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Before group; Mechanically ventilated emergency department patients receiving standard neuromuscular blockers prior to an educational initiative on the importance of ED-based targeted shorter acting neuromuscular blocker.	Other: Standard neuromuscular blocker practices; Usual care neuromuscular blocker in the ED
Experimental: After group; Mechanically ventilated emergency department patients receiving neuromuscular blockers after an educational initiative aimed at improving use of shorter acting neuromuscular blocker practices in the ED.	Behavioral: Education; Nurses and physicians will be engaged regarding the clinical outcome data on the importance of shorter acting neuromuscular blockers, and the objectives of the research. Education will include in-services and lectures focused on the importance of neuromuscular blocker protocols on patient outcome. The use of neuromuscular blokers will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based neuromuscular blocker protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.	The modified Brice questionnaire will be used in this trial.	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD symptoms	Will be measured using the PCL-5, a validated 20-item (score 0-4, Likert scale) self-reported measure that assesses 20 DSM-5 symptoms of PTSD.	30 days
PTSD symptoms	Will be measured using the PCL-5, a validated 20-item (score 0-4, Likert scale) self-reported measure that assesses 20 DSM-5 symptoms of PTSD.	180 days
Depression and Anxiety	Hospital Anxiety and Depression Scale (HADS), a validated 14-item (7 depression, 7 anxiety, ordinal score 0-3) questionnaire commonly used in critical illness	30 days
Depression and Anxiety	Hospital Anxiety and Depression Scale (HADS), a validated 14-item (7 depression, 7 anxiety, ordinal score 0-3) questionnaire commonly used in critical illness	180 days
Health Related Quality of Life (QOL)	EuroQol-5D (EQ-5D), the most widely used scale for measuring health-related QOL and part of the core sets recommended for critical care studies on post-discharge outcomes	30 days
Health Related Quality of Life (QOL)	EuroQol-5D (EQ-5D), the most widely used scale for measuring health-related QOL and part of the core sets recommended for critical care studies on post-discharge outcomes	180 days

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Brian Fuller, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Fuller BM, Driver BE, Roberts MB, Schorr CA, Thompson K, Faine B, Yeary J, Mohr NM, Pappal RD, Stephens RJ, Yan Y, Johnson NJ, Roberts BW. Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial. Trials. 2023 Nov 25;24(1):753. doi: 10.1186/s13063-023-07764-5.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Intubation; Paralysis; Awareness; Rocuronium; Emergancy Department
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Paralysis; Stress Disorders, Post-Traumatic; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 202207132; 1R01HL162721-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will consider sharing IPD upon reasonable request
• IPD Sharing Time Frame: Starting 6 months after all publications related to the data.
• IPD Sharing Access Criteria: Can be obtained by contacting the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No