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NCT Number: NCT07585578

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

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.

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Key information

Conditions

Post-Intensive Care Syndrome (PICS) postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Wanbei Rehabilitation Hospital, Huaibei, Anhui, China

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About this study

This multi-center observational study aims to characterize the epidemiological profile and multidimensional functional impairments of Post-Intensive Care Syndrome (PICS) in ICU survivors across China. The study will enroll approximately 800 eligible participants from four participating high-dependency units (HDUs) between January 2018 and January 2026. Data on physical, cognitive, and psychological function will be collected using validated assessment tools including the MRC score, ICU Mobility Scale, CPAx, MMSE, S5Q, PHQ-9, GAD-7, PSQI, Barthel Index, and EQ-5D-5L. The primary outcomes include the incidence of PICS and comorbidity patterns across multiple functional domains. The secondary outcomes encompass functional status, quality of life, and risk factors for PICS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • First admission to ICU, with ICU length of stay ≥ 48 hours before transfer to HDU
  • Complete the PICS assessment within 7 days after HDU admission
  • Complete clinical data available (demographics, ICU-related information)
  • Signed informed consent obtained from participants or legal guardians

Exclusion criteria

  • Prior ICU admission
  • Terminal illness or estimated life expectancy <6 months
  • Participants or family members refuse to complete questionnaires

Treatment and study plan

Data Collection and Assessment

Other
  • 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.
  • 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.
  • Cognitive function assessment: Standardized Five Questions，Mini-Mental State Examination.
  • 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.
  • Quality of life and functional capacity: Barthel Index, EQ-5D-5L.

Primary outcomes

  1. MRC Sum Score for Muscle Strength

    Time frame: 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.

  2. ICU Mobility Scale Score

    Time frame: 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.

  3. Chelsea Critical Care Physical Assessment Tool Score

    Time frame: 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.

  4. Mini-Mental State Examination Score

    Time frame: 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.)

  5. PHQ-9 Score for Depression

    Time frame: 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.

  6. GAD-7 Score for Anxiety

    Time frame: 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.

  7. Pittsburgh Sleep Quality Index Global Score

    Time frame: 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.

  8. Brief Pain Inventory-9 Pain Severity Score

    Time frame: 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.

  9. Hospital Anxiety and Depression Scale Score for Family Caregivers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongying Jiang, MD

CONTACT

[email protected]

+861056981098

Jingyi Ge

CONTACT

[email protected]

+861056981098

Sponsors and collaborators

Lead sponsor

Hongying Jiang, MD

Other

Registry information

Official study title

Multidimensional Dysfunction in Patients With Post-Intensive Care Syndrome in China: A Multi-center Real-world Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 14, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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