Multidimensional Dysfunction in Patients With Post-Intensive Care Syndrome in China
1 other identifier
observational
800
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2026
CompletedStudy Start
First participant enrolled
May 12, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
June 11, 2026
June 1, 2026
8 months
May 1, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
MRC Sum Score for Muscle Strength
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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
ICU Mobility Scale Score
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.
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 Score
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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Mini-Mental State Examination Score
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.)
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
PHQ-9 Score for Depression
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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
GAD-7 Score for Anxiety
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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Pittsburgh Sleep Quality Index Global Score
Pittsburgh Sleep Quality Index (PSQI) assessing sleep quality. Global score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Brief Pain Inventory-9 Pain Severity Score
Brief Pain Inventory-9 (BPI-9) pain severity score. Total score ranges from 0 to 10. Higher scores indicate more severe pain.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Hospital Anxiety and Depression Scale Score for Family Caregivers
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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
Study Arms (1)
post-intensive care syndrome group
PICS patients who come from a general hospital ICU and are transferred to a participating HDU
Interventions
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.
Eligibility Criteria
This study is a multi-center, retrospective, observational cohort study that will enroll patients from four participating high-dependency units (HDUs) across China. Patients transferred from general hospital ICUs to the participating HDUs between January 2018 and January 2026 will be screened. Data will be sourced from medical records, nursing records, rehabilitation assessment records, and follow-up documentation from routine clinical care. The anticipated total sample size is 800 participants.
You may qualify if:
- 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
You may not qualify if:
- Prior ICU admission
- Terminal illness or estimated life expectancy \<6 months
- Participants or family members refuse to complete questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Anhui Wanbei Rehabilitation Hospital
Huaibei, Anhui, China
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043, China
Hunan Rehabilitation Hospital
Hunan, Hunan, 410000, China
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Henan, Zhengzhou, 450007, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
May 1, 2026
First Posted
May 14, 2026
Study Start
May 12, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
May 31, 2027
Last Updated
June 11, 2026
Record last verified: 2026-06