Clinical trial NCT05534243: The ED-AWARENESS-2 Trial
Official title: Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Awareness
Mechanical Ventilation
Intubation Complication
PTSD
Keywords: Awareness
Paralysis
Emergancy Department
Rocuronium
Mechanical Ventilation
Intubation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-09-09
Enrollment: 3090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicenter, stepped wedge, cluster randomized trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.
timeFrame: up to 30 days
Secondary outcomes:
measure: PTSD symptoms
timeFrame: 30 days
measure: PTSD symptoms
timeFrame: 180 days
measure: Depression and Anxiety
timeFrame: 30 days
measure: Depression and Anxiety
timeFrame: 180 days
measure: Health Related Quality of Life (QOL)
timeFrame: 30 days
measure: Health Related Quality of Life (QOL)
timeFrame: 180 days
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Roy J. and Lucille A. Carver College of Medicine
state: Iowa
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Camden
country: United States
facility: Cooper University Hospital/Cooper Medical School of Rowan University
state: New Jersey
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Brian Fuller, MD
role: PRINCIPAL_INVESTIGATOR
References: