Characterizing and Quantifying Pain After Cardiac Arrest and Resuscitation: Insights From the PAINCARE Substudy of the STEPCARE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Restricted mean time (hours) in moderate/severe pain while alive and in ICU by 168 h
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Restricted mean time (hours) in moderate/severe pain while alive and in ICU by 168 h
时间窗: From enrollment to 168 hours
The primary outcome is the restricted mean time (hours) that patients spend in moderate or severe pain during the first 168 hours (7 days) of ICU care after cardiac arrest, while alive and in the ICU. Pain intensity is assessed at regular intervals using validated behavioral or self-report scales: the Behavioral Pain Scale (BPS, range 3-12; \>5 = moderate/severe pain), the Critical Care Pain Observation Tool (CPOT, range 0-8; \>2 = moderate/severe pain), or the Numeric Rating Scale (NRS, 0-10; \>3 = moderate/severe pain). Each assessment reflects the highest observed pain since the previous timepoint, allowing calculation of total time spent in moderate/severe pain across the first 7 days.
次要结局
- Proportion of time spent in moderate or severe pain during the first 168 hours(Enrollment to 168 hours)
- Delirium-free days alive in the ICU by 168 hours(Enrollment to 168 hours)
- Proportion of patients achieving a mobility level greater than 1(Enrollment to 168 hours)
- Hours alive and free of invasive ventilation by day 30(Enrollment to day 30)
- ICU-free days alive at day 30(Enrollment to day 30)
- Self-reported NRS score at 1 month(1 month)
- Self-reported NRS score at 6 months(6 months)
- Self-reported WVS score at 6 months(6 months)