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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07585578
Enrollment
800
Registered
2026-05-14
Start date
2026-05-12
Completion date
2027-05-31
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Intensive Care Syndrome (PICS)

Keywords

Post-Intensive Care Syndrome (PICS), High-dependency unit, functional outcome

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.

Detailed description

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.

Interventions

OTHERData 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.

Sponsors

Hongying Jiang, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MRC Sum Score for Muscle StrengthCollect 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 ScoreCollect 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 ScoreCollect 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 ScoreCollect 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 DepressionCollect 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 AnxietyCollect 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 ScoreCollect 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 ScoreCollect 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 CaregiversCollect 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.

Countries

China

Contacts

CONTACTJingyi Ge
ge_jingyi2020@163.com+861056981098
CONTACTHongying Jiang, MD
6jhy@163.com+861056981098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026