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. 2023 Dec 9;13(12):e078645. doi: 10.1136/bmjopen-2023-078645

Table 1.

Secondary outcomes, measurement tool or method, and timing

Outcome Measurement tool or method Timing
Mortality Medical records check ICU, hospital, 30, 90 and 180 days post randomisation
Length of ICU stay
Number of days the participant is in ICU		 Medical record ICU discharge
Sedation and analgesia quality
Lowest and highest RASS score per day over time during intervention
Quality of sedation using SQAT states (daily basis); days with optimum sedation, agitation, or unnecessary deep sedation (RASS -4/–5).
Quality of analgesia using presence of pain behaviour (daily basis) based on limb response to movement and ventilation compliance		 Richmond Agitation and Sedation Scale (RASS)
Sedation Quality (based on Sedation Quality Assessment Tool (SQAT)).27 Two components of the SQAT pain assessment will be used in this trial to measure sedation quality (limb relaxation and compliance with ventilation)
Defines four states for sedation quality:

  1. Overall optimum sedation (no agitation; no unnecessary deep sedation; no pain behaviour)

  2. Agitation

  3. Unnecessary deep sedation (RASS -4/–5 without clinical indication)

  4. Pain (presence of pain behaviour based on limb response to movement and ventilation compliance)

 Four hourly during ICU stay until primary outcome is reached
Derived from daily sedation and analgesia quality data during intervention period in ICU until primary outcome is reached
Time to first optimum sedation hours
Hours from randomisation to first ‘light’ sedation (RASS score of −2 or greater)
Days from randomisation to first day with optimum sedation (based on SQAT definition)		 RASS scores 4 hourly during ICU stay
SQAT status (daily during ICU stay)		 Based on daily sedation and pain assessments during the intervention period
Delirium prior to successful extubation
Occurrence prior to successful extubation (binary outcome)
Days with delirium (CAM-ICU positive) or coma (RASS score -4/–5) prior to successful extubation (continuous outcome)		 Confusion Assessment Method for the ICU (CAM-ICU)28 Twice daily during ICU stay until primary outcome is reached
Drug-related adverse events
Number of patients experiencing a predefined adverse event and each defined adverse event
Number of days prior to successful extubation that any predefined adverse event occurred, and each defined adverse event occurred.		 Severe bradycardia; cardiac arrhythmias; cardiac arrest (defined in protocol); ileus Daily during the intervention period
Health-related quality of Life
HRQoL at 30, 90 and 180 days post randomisation		 EuroQol tool (EQ-5D-5L) Recalled HRQoL prior to hospital admission; prospective measurement 30, 90 and 180 days post randomisation
Patients’ ability to communicate pain and ability to cooperate with care
Number of days on which pain could be communicated during intervention (binary score)
Number of days on which patient was able to cooperate with care (binary score)		 Binary assessment for each 12 hours nursing shift requested from bedside nurse (based on overall assessment of period of care). Answer to the following questions:

  1. Was your patient able to communicate pain?

  2. Was your patient able to cooperate with care?

 Twice daily until primary outcome is reached
Patient experience of ICU care
ICE-Q score at 90 days post-randomisation overall for each domain		 Intensive Care Experience Questionnaire (ICE-Q)29
Provides numeric score in four domains:

  1. Awareness of surroundings

  2. Frightening experiences

  3. Recall of experiences

  4. Satisfaction with care

 90 days post randomisation
Relative/partner/friend (PerLR) assessment of comfort and communication
Daily response to each of the three questions (binary outcome)		 Relative/partner/friends response to the following questions (based on their opinion at time of assessment):

  1. Does the patient appear awake to the visitor?

  2. Does the patient seem comfortable to the visitor?

  3. Does the visitor feel they can communicate with the patient?

 Daily at a visit until primary outcome is reached
Anxiety and depression
HADS score at 180 days post randomisation		 Hospital Anxiety and Depression Scale (HADS) questionnaire 180 days post randomisation
Post-traumatic stress
Impact of Events Scale-revised (IES-R) score at 180 days post-randomisation		 Impact of Events Scale-revised (IES-R) 180 days post randomisation
Cognitive function
TMoCA score at 180 days post randomisation		 Montreal Cognitive Assessment Tool (Telephone version) (TMoCA) 180 days post randomisation

ICU, intensive care unit.