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

Overview

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.

Interventions

• 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.

Primary outcome measures

• The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire. [Time frame: up to 30 days]

Secondary outcome measures (6)

• PTSD symptoms [Time frame: 30 days]
• PTSD symptoms [Time frame: 180 days]
• Depression and Anxiety [Time frame: 30 days]
• Depression and Anxiety [Time frame: 180 days]
• Health Related Quality of Life (QOL) [Time frame: 30 days]
• Health Related Quality of Life (QOL) [Time frame: 180 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Crossover

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Roy J. and Lucille A. Carver College of Medicine — Iowa City
• Hennepin Healthcare — Minneapolis
• Cooper University Hospital/Cooper Medical School of Rowan University — Camden
• University of Washington School of Medicine — Seattle

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 PMID 38001507

Identifiers

NCT: NCT05534243 · 202207132 · 1R01HL162721-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗