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Table 1 Schedule of screening, data collection, and outcomes assessments for the ED-AWARENESS-2 Trial

From: 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

Measurement/event

ED

Extubation

a1

2

3

4

5

6

7

MVb

HOSP D/C

Day 30

Day 180

Inclusion criteria

X

            

Exclusion criteria

 

X

           

Demographics, baseline data

X

            

Laboratory values

X

            

Blood gas values

X

 

X

          

ED procedures and care

X

            

Intubation meds and location

X

            

Safety events (i.e., intubation success, unplanned extubation, cardiac arrhythmia, allergy, MH)

X

            

Ventilator settings/data

X

            

Sedation depth (RASS, SAS), documented by bedside nurse

X

 

X

X

X

X

X

X

X

    

Medications for sedation, analgesia, NMB

X

 

X

          

Delirium assessment/CAM-ICU

  

X

X

X

X

X

X

X

    

Assessment of AWP

 

X

           

Ventilator duration

         

X

X

  

Length of stay (hospital and ICU)

          

X

  

Discharge location

          

X

  

Mortality status

          

X

  

Mental health and QOL assessments

           

X

X

  1. ED emergency department; MV mechanical ventilation; MH malignant hyperthermia; RASS Richmond Agitation-Sedation Scale; SAS Sedation-Agitation Scale; NMB neuromuscular blockade; CAM confusion assessment method; ICU intensive care unit; QOL quality of life
  2. aThe numbers 1–7 refer to hospital days, with hospital day 1 referring to the first day after admission from the ED
  3. bIf patient is extubated for 24 h or more, then that is the end of ventilation duration. If patient is extubated and re-intubated within 24 h, this is treated as though they were never extubated
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ISSN: 1745-6215