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Table 1 Definition of outcome measures

From: Impact of a multifaceted early mobility intervention for critically ill children — the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial

Primary outcome

 Days alive and ventilator-free (AVF)

Days when the patient was alive, and an endotracheal tube was absent for 24 continuous hours during a calendar daya,b through 21 days

Secondary outcomes

 Days alive and delirium- and coma-free (ADCF)

Days when the patient was alive, without delirium, and coma-free for 24 continuous hours during a calendar dayb,c,d through 21 days

 Days alive and coma-free (ACF)

Days when the patient was alive, and coma-free for 24 continuous hours during a calendar dayb,d through 21 days

 Days alive

Days when the patient was alive for 24 h during a calendar daye through 21 days

 Functional status

Pediatric Cerebral Performance Category and Pediatric Overall Performance Category scores assessed at the earlier of PICU discharge or day 21

Exploratory outcomes

 PICU length of stay

Number of days on which the patient was physically present in the PICU rounded to the nearest higher day through 21 days

 PICU mortality

Number of patients deceased or withdrawn from the study for limitation of care orders or brain death evaluation/total enrolled patients

 PICU and hospital discharge destination

Number of patients discharged to home, inpatient floor, inpatient, rehabilitation, other hospitals/number of discharged patients

 New pressure injuries

Rate of new pressure injuries/eligible patient days through 21 days

 Opioid exposure

Opioid dose (mg/kg/day) measured in morphine milligram equivalents (MME)f

 Benzodiazepines exposure

Benzodiazepine dose (mg/kg/day) measured in midazolam milligram equivalentsg

  1. a For patients with a tracheostomy, a ventilator-free day will be defined as a day when the patient is not receiving invasive mechanical ventilation for 24 continuous hours during a calendar day. Specifically, patients with a tracheostomy whose breaths are unassisted (i.e., trach collar) will be considered ventilator-free; patients receiving assisted breaths (i.e., CPAP) will not be considered ventilator-free
  2. b Days following PICU discharge to 21 days will be considered days alive, ventilator-, delirium- and coma-free, with the following exceptions: days after PICU discharge will not be considered days alive for deceased patients, days after PICU discharge will not be considered days ventilator-free if the patient remains intubated at discharge
  3. c Delirium-free days are days when the patient is at risk of delirium (i.e., coma-free) and delirium was not present
  4. d Coma-free days are days when all documented sedation scores are above the following thresholds: SBS ≥ − 1; RASS ≥ −3; COMFORT-B ≥ 10
  5. e For patients who were withdrawn from the study due to limitation of care orders or brain death evaluations, they will be considered deceased on the day death is pronounced
  6. f The following conversion will be used: fentanyl: 10 mcg = 1 MME; hydromorphone: 0.25 mg = 1 MME; morphine 1 mg = 1 MME [42]
  7. g The following conversion will be used: lorazepam: 0.5 mg = 1 midazolam milligram equivalents; midazolam: 1 mg = 1 midazolam milligram equivalents [43]
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