Multidimensional Dysfunction in Patients With Post-Intensive Care Syndrome in China

Condition(s) studied

Investigational drug(s) / intervention(s)

Data Collection and Assessment: 1. General clinical data collection: demographic characteristics, primary disease, duration of tracheostomy tube retention, duration of mechanical ventilation before transfer, and length of ICU stay before transfer; history of organ dysfunction; tube/catheter status; disease severity; nutritional status. 2. Physical function assessment: diaphragmatic excursion, diaphragm thickness, thickening fraction, PEF; Medical Research Council score for muscle strength, ICU Mobility Scale; comprehensive score: Chelsea Critical Care Physical Assessment Tool score. 3. Cognitive function assessment: Standardized Five Questions，Mini-Mental State Examination. 4. Psychological status assessment: Patient Health Questionnaire-9 for depression, Generalized Anxiety Disorder 7-item scale , Pittsburgh Sleep Quality Index, Brief Pain Inventory-9, Hospital Anxiety and Depression Scale for family caregivers. 5. Quality of life and functional capacity: Barthel Index, EQ-5D-5L.

Study summary

Over the past two decades, the rapid advancement of critical care medicine has significantly reduced short-term mortality among critically ill patients. However, a growing number of intensive care unit (ICU) survivors experience persistent physical, cognitive, and psychological impairments after hospital discharge, a syndrome termed post-intensive care syndrome (PICS). Although PICS has gained increasing attention in recent years, existing studies still have multiple limitations. Given the continuously increasing number of ICU survivors in China and the marked heterogeneity in critical care delivery models across different regions and healthcare institutions, there is an urgent need for large-scale multicenter observational studies to systematically characterize the epidemiological features, multidimensional functional impairment profiles, and clinical impact of PICS in Chinese patients, thereby providing an evidence-based foundation for the development of a scientific post-ICU continuum of care.

Eligibility

Primary outcome measure(s)

• MRC Sum Score for Muscle Strength — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  MRC (Medical Research Council) sum score assessing muscle strength. Total score ranges from 0 (complete quadriplegia) to 60 (normal bilateral muscle strength). Higher scores indicate better muscle strength.
• ICU Mobility Scale Score — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  ICU Mobility Scale (IMS) assessing mobility level in ICU patients. Total score ranges from 0 (lying in bed, not active) to 10 (walking independently). Higher scores indicate better mobility.
• Chelsea Critical Care Physical Assessment Tool Score — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  Chelsea Critical Care Physical Assessment Tool (CPAx) comprehensively evaluating physical function in ICU patients. Total score ranges from 0 to 50. Higher scores indicate better physical function.
• Mini-Mental State Examination Score — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  Mini-Mental State Examination (MMSE) assessing cognitive function. Total score ranges from 0 to 30. Higher scores indicate better cognitive function. (Chinese validated version will be used.)
• PHQ-9 Score for Depression — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  Patient Health Questionnaire-9 (PHQ-9) assessing severity of depressive symptoms. Total score ranges from 0 to 27 (0-4: none, 5-9: mild, 10-14: moderate, 15-19: moderately severe, 20-27: severe). Higher scores indicate worse depression.
• GAD-7 Score for Anxiety — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  Generalized Anxiety Disorder 7-item scale (GAD-7) assessing severity of anxiety symptoms. Total score ranges from 0 to 21 (0-4: none, 5-9: mild, 10-14: moderate, 15-21: severe). Higher scores indicate worse anxiety.
• Pittsburgh Sleep Quality Index Global Score — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  Pittsburgh Sleep Quality Index (PSQI) assessing sleep quality. Global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
• Brief Pain Inventory-9 Pain Severity Score — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  Brief Pain Inventory-9 (BPI-9) pain severity score. Total score ranges from 0 to 10. Higher scores indicate more severe pain.
• Hospital Anxiety and Depression Scale Score for Family Caregivers — Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
  Hospital Anxiety and Depression Scale (HADS) assessing psychological status of family caregivers. Each subscale (anxiety and depression) ranges from 0 to 21. Higher scores indicate worse psychological distress.

Trial sites (4)

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