The ED-AWARENESS-2 Trial

PTSD Clinical Trial

— ED-AWARENES II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534243
• Other study ID #: 202207132
• Secondary ID: 1R01HL162721-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Brian Fuller, MD
• Phone: 314-747*5368
• Email: fullerb[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3090
• Est. completion date: September 1, 2027
• Est. primary completion date: March 1, 2027
• 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

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

Related Conditions & MeSH terms

• Awareness
• Intubation Complication
• Mechanical Ventilation
• Paralysis
• PTSD

Intervention

Other:
• Standard neuromuscular blocker practices
Usual care neuromuscular blocker 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.

Locations

Country	Name	City	State
United States	Cooper University Hospital/Cooper Medical School of Rowan University	Camden	New Jersey
United States	Roy J. and Lucille A. Carver College of Medicine	Iowa City	Iowa
United States	Hennepin Healthcare	Minneapolis	Minnesota
United States	University of Washington School of Medicine	Seattle	Washington

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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