AwarenessED-AWARENES IINCT05534243
The ED-AWARENESS-2 Trial
A study testing Standard neuromuscular blocker practices and Education in people with Awareness and Mechanical Ventilation, run by Washington University School of Medicine at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awareness, Mechanical Ventilation, Intubation Complication
- What is being tested?
- Standard neuromuscular blocker practices and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,212 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jun 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Cooper University Hospital/Cooper Medical School of Rowan University
Camden, New Jersey, 08103
Brian Roberts, MD, Msc, 856-342-2352, roberts-brian-w@cooperhealth.edu
Brian W Roberts, MD
- Recruiting
Roy J. and Lucille A. Carver College of Medicine
Iowa City, Iowa, 52242
Nicholas Mohr, MD, MS, 319-384-8285, Nicholas-mohr@uiowa.edu
Brett Faine, PharmD, MS, 319-384-5228, brett-faine@uiowa.edu
- Recruiting
Hennepin Healthcare
Minneapolis, Minnesota, 55415
Brian E Driver, MD, 612-873-7448, brian.driver@hcmed.org
Brian E Driver, MD
- Recruiting
University of Washington School of Medicine
Seattle, Washington, 98195
Megan Fuentes, BS, 206-744-5888, mrf2@uw.edu
Nicholas J Johnson, MD
About this study
Official title: 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.
- Conditions
- Awareness, Mechanical Ventilation, Intubation Complication, PTSD
- Being tested
- Standard neuromuscular blocker practices, Education
- Keywords
- Awareness, Paralysis, Emergancy Department, Rocuronium, Mechanical Ventilation, Intubation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard neuromuscular blocker practicesOther
Usual care neuromuscular blocker in the ED
EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Before group | Active comparator | 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. Receives: Other: Standard neuromuscular blocker practices |
| After group | Experimental | 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.
The modified Brice questionnaire will be used in this trial.
Measured: up to 30 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start28 Jun 2023
- Primary completion30 Jun 2026
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AwarenessStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Multicenter, stepped wedge, cluster randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Brian Fuller, Washington University School of Medicine
- Investigators
- Brian Fuller, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534243
- Sponsor's protocol ID
- 202207132
- Other IDs
- 1R01HL162721-01A1
- Acronym
- ED-AWARENES II
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will consider sharing IPD upon reasonable request
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.
PubMed 38001507
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial
- ClinicalTrials.gov ID
- NCT05534243
- Acronym / sponsor ID
- ED-AWARENES II / 202207132
- Conditions
- Awareness, Mechanical Ventilation, Intubation Complication, PTSD
- Keywords
- Awareness, Paralysis, Emergancy Department, Rocuronium, Mechanical Ventilation, Intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,212 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, stepped wedge, cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Before group | Active comparator | Other: Standard neuromuscular blocker practicesMechanically ventilated emergency department patients receiving standard neuromuscular blockers prior to an educational initiative on the importance of ED-based targeted shorter acting neuromuscular blocker. |
| After group | Experimental | Behavioral: EducationMechanically ventilated emergency department patients receiving neuromuscular blockers after an educational initiative aimed at improving use of shorter acting neuromuscular blocker practices in the ED. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard neuromuscular blocker practicesUsual care neuromuscular blocker in the ED | Other | Before group |
| EducationNurses 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. | Behavioural | After group |
Primary outcome
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.
Time frame: up to 30 days
The modified Brice questionnaire will be used in this trial.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 38001507Fuller 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.
- Individual participant dataSharing planned: Yes. We will consider sharing IPD upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Fuller, MD principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard neuromuscular blocker practices and Education in people with Awareness and Mechanical Ventilation, run by Washington University School of Medicine at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Fuller, MD (314-747*5368, fullerb@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire. (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.