Out-of-hospital Cardiac Arrest (OHCA), Pain
Conditions
Keywords
Chest compressions, delirium, quality of life, Cardiopulmonary resuscitation, Mechanical ventilation, ICU length of stay, critical care, cardiac arrest survivors, pain assessment
Brief summary
The PAINCARE substudy is an observational cohort substudy nested within the international STEPCARE trial, which evaluates sedation, temperature, and mean arterial pressure strategies after out-of-hospital cardiac arrest. PAINCARE aims to describe the burden of pain during early intensive care after cardiac arrest and to evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Pain is common in critically ill patients but may be difficult to assess in patients who are unconscious, sedated, mechanically ventilated, or unable to self-report. PAINCARE collects structured pain assessments during the first 168 hours after randomization using validated self-report or behavioral pain instruments and relates early pain burden to outcomes including delirium burden, ventilator-free time, ICU-free time, and follow-up pain outcomes. All analyses are observational; PAINCARE is not designed to determine whether modifying pain burden improves outcomes.
Detailed description
PAINCARE is an exploratory observational substudy. The available sample size is expected to be approximately 300 participants and will be determined by PAINCARE participation, consent status, availability of PAINCARE data, and eligibility for the relevant analysis population. The primary analysis will estimate cumulative time in moderate/severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Secondary analyses will evaluate associations between early pain burden and selected ICU and patient-reported outcomes. Missingness will be reported by variable, timepoint, site, and ascertainment mode where feasible. Prespecified analysis rules distinguish missing scorable intervals from non-scorable intervals, allow deterministic imputation only for isolated missing scorable intervals meeting prespecified criteria, and use endpoint-specific analysis populations for secondary and exploratory analyses. Sensitivity analyses will assess robustness to assumptions about pain-data completeness, deterministic imputation, non-scorable intervals, pain-state thresholds, and ascertainment mode. Analyses will be primarily descriptive and associational; findings outside the primary analysis will be considered hypothesis-generating. PAINCARE includes both retrospectively and prospectively ascertained participants according to local approvals and substudy implementation.
Interventions
None listed
Sponsors
Region Skane
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Out-of-hospital cardiac arrest * Adult, age 18 years or older * Spontaneous circulation without chest compressions for at least 20 minutes * Comatose, defined as not obeying verbal commands * Enrolled within 4 hours after return of spontaneous circulation
Exclusion criteria
* Restrictions or limitations of care * On extracorporeal membrane oxygenation before randomization * Pregnancy * Previously randomized in the STEPCARE trial * Trauma or hemorrhage as the presumed cause of arrest * Suspected or confirmed intracranial hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Time in Moderate or Severe Pain While Alive and in the ICU Through 168 Hours | From randomization through 168 hours, ICU discharge, or death, whichever occurs first | Cumulative time, in hours, spent in moderate or severe pain while alive and in the ICU from randomization through 168 hours, ICU discharge, or death, whichever occurs first. Moderate or severe pain is defined as NRS \>3, CPOT \>2, or BPS \>5. Each scheduled assessment represents the worst pain intensity since the previous assessment and is assigned to the corresponding preceding interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Evaluable Alive-in-ICU Time Spent in Moderate or Severe Pain Through 168 Hours | From randomization through 168 hours, ICU discharge, or death, whichever occurs first | Proportion of evaluable alive-in-ICU time spent in moderate or severe pain during the primary 0- to 168-hour pain-burden window. The proportion is calculated as cumulative evaluable time in moderate or severe pain divided by total evaluable alive-in-ICU time, excluding time after ICU discharge or death and excluding non-scorable and remaining missing scorable intervals. |
| Delirium Burden Through 168 Hours | From randomization through 168 hours | Proportion of evaluable point-prevalence delirium assessments with delirium present among assessments recorded as delirium present or absent through 168 hours. Delirium is assessed using the Confusion Assessment Method for the ICU or the Intensive Care Delirium Screening Checklist. Assessments recorded as not assessable are reported separately and do not contribute to the denominator; assessments recorded as not done are reported as missing. |
| Hours Alive and Free of Invasive Ventilatory Support Through Day 30 | From randomization through day 30 | Number of hours from randomization to day 30 during which the participant is alive and not receiving invasive ventilatory support. Participants who die before day 30 are assigned zero hours alive and free of invasive ventilatory support. |
| ICU-Free Days Alive Through Day 30 | From randomization through day 30 | Number of days from randomization to day 30 during which the participant is alive and discharged from the ICU. Participants who die before day 30 are assigned zero ICU-free days. |
| Moderate or Severe Pain at 1 Month | At 1 month | Moderate or severe pain at the 1-month follow-up assessment, defined as Numeric Rating Scale score greater than 3 for worst pain on movement during the preceding 24 hours. |
Countries
Sweden
Contacts
CONTACTJoachim P Düring, MD, PhD
CONTACTMia H Hylén, RN, PhD
PRINCIPAL_INVESTIGATORJoachim P Düring, MD, PhD
Lunds Universitet, Institutionen för kliniska vetenskaper, Lund, Anesthesia and Intensive Care, Skåne University Hospital , Malmö, Sweden
Outcome results
None listed