Multidimensional Dysfunction in Patients With Post-Intensive Care Syndrome in China
ConditionPost-Intensive Care Syndrome (PICS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHongying Jiang, MD
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Prior ICU admission
Terminal illness or estimated life expectancy <6 months
Participants or family members refuse to complete questionnaires
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Data Collection and Assessment
Other intervention1. 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.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: post-intensive care syndrome group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.2
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.
Time frame
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.3
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.
Time frame
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.4
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.)
Time frame
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hongying Jiang, MD
Lead sponsor
Capital Medical University
Sponsor institution
Source ClinicalTrials.gov