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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Data 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 sco

Первичные конечные точки

• MRC Sum Score for Muscle Strength [Срок оценки: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
• ICU Mobility Scale Score [Срок оценки: 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 [Срок оценки: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
• Mini-Mental State Examination Score [Срок оценки: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
• PHQ-9 Score for Depression [Срок оценки: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]
• GAD-7 Score for Anxiety [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 4 центра

• Anhui Wanbei Rehabilitation Hospital — Huaibei
• Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China — Пекин
• Hunan Rehabilitation Hospital — Hunan
• Zhengzhou Central Hospital Affiliated to Zhengzhou University — Henan

Идентификаторы

NCT: NCT07585578 · 2026bkky-dzx-PICS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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