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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Intensive Care Syndrome (PICS)
• Intervention / Treatment: Other: Data Collection and Assessment

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 participants from six participating centers (three high-dependency units from 2018-2026 and three ICUs from 2025-2026). Data on physical, cognitive, and psychological function will be collected using validated assessment tools including MRC, ICU Mobility Scale, CPAx, MMSE, S5Q, PHQ-9, GAD-7, PSQI, Barthel Index, and EQ-5D-5L. Primary outcomes include the incidence of PICS and comorbidity patterns across multiple functional domains. Secondary outcomes encompass functional status, quality of life, and risk factors for PICS.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Jingyi Ge; Phone Number: +861056981098; Email: ge_jingyi2020@163.com
• Study Contact Backup: Name: Hongying Jiang, MD; Phone Number: +861056981098; Email: 6jhy@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100043
      • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This study is a multi-center, retrospective, observational cohort study that will enroll patients from six participating centers across China, including three high-dependency units (HDUs) and three ICUs. For the HDU component, patients transferred from general hospital ICUs to the participating HDUs between January 2018 and January 2026 will be screened. For the ICU component, patients scheduled for discharge directly from the participating ICUs between January 2025 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.

Description

Inclusion Criteria:

• Age ≥18 years
• Admitted to ICU from participating general hospitals and transferred to participating High-Dependency Units (HDUs) or discharged directly from participating ICUs
• First ICU admission with ICU length of stay ≥48 hours
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

post-intensive care syndrome group; PICS patients who come from a general hospital ICU and are transferred to a participating HDU, or who are planned for discharge from a participating ICU.

Other: Data Collection and Assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Hongying Jiang, MD

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: functional outcome; Post-Intensive Care Syndrome (PICS); High-dependency unit
• Additional Relevant MeSH Terms: postintensive care syndrome; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavior Control; Immobilization; Restraint, Physical; Data Collection
• Other Study ID Numbers: 2026bkky-dzx-PICS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No