Multidimensional Dysfunction in Patients With Chronic Critical Illness in China

NCT07585578 | Recruiting DMC

• 1 other identifier: 2026bkky-dzx-CCI
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 4

Brief Summary

Over the past two decades, rapid advances in critical care medicine have markedly reduced short-term mortality among critically ill patients. As a result, a growing number of patients survive the acute phase of critical illness but do not recover quickly. Instead, they develop chronic critical illness (CCI), which is characterized by prolonged dependence on intensive care, including prolonged mechanical ventilation, persistent organ dysfunction, recurrent infections, and extended intensive care unit (ICU) stay. Patients with CCI have a heavy symptom burden and consume substantial healthcare resources, and many survivors experience persistent physical, cognitive, and psychological impairments after hospital discharge. Although CCI has gained increasing attention in recent years, existing studies still have multiple limitations. The number of patients with CCI in China continues to rise, and critical care delivery models vary widely across regions and healthcare institutions. There is therefore an urgent need for a large-scale multicenter observational study to systematically characterize the epidemiological features, multidimensional functional impairment profiles, and long-term functional outcomes of Chinese patients with CCI. The findings will provide an evidence-based foundation for developing a scientific post-ICU continuum of care for this population.

Conditions

Critical Illness

Keywords

Critical Illness; High-dependency unit; functional outcome

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)

Patients With Chronic Critical Illness

Adult patients with chronic critical illness (CCI) admitted to four participating high-dependency units (HDUs) in China.

Other: Data Collection and Assessment

Interventions

Data Collection and Assessment OTHER

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.

Patients With Chronic Critical Illness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This multicenter retrospective cross-sectional observational study included consecutive adults with chronic critical illness (CCI) transferred from ICUs to four participating high-dependency units (HDUs) in China between January 2018 and January 2026. CCI was defined as a post-ICU state in which patients no longer required full ICU-level care but remained clinically dependent, required continued HDU treatment, and could not be discharged directly home or return to community living. Data were obtained from routine medical, nursing, rehabilitation, and clinical records. Cognitive, physical, and psychological assessments were completed within 7 days of HDU admission, and family caregivers were assessed using the Hospital Anxiety and Depression Scale.

You may qualify if:

• Adults aged 18 years or older.
• Patients with chronic critical illness (CCI), operationally defined as patients transferred from an intensive care unit (ICU) to a participating high-dependency unit (HDU) who no longer required full ICU-level care but remained clinically dependent, required continued inpatient treatment in an HDU, and could not be discharged directly home or return to community living.
• Completion of cognitive, physical, and psychological assessments within 7 days after HDU admission.

You may not qualify if:

• No identifiable family caregiver available to complete the Hospital Anxiety and Depression Scale assessment.
• A documented diagnosis of dementia or a chronic psychiatric disorder requiring continuous pharmacological treatment before the index ICU admission.
• Admission to the HDU exclusively for end-of-life or palliative care.

Sponsors & Collaborators

• Hongying Jiang, MD: lead

Study Sites (4)

Anhui Wanbei Rehabilitation Hospital

Huaibei, Anhui, China

NOT YET RECRUITING

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, 100043, China

RECRUITING

Hunan Rehabilitation Hospital

Hunan, Hunan, 410000, China

NOT YET RECRUITING

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Henan, Zhengzhou, 450007, China

NOT YET RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Data Collection; Restraint, Physical

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Jingyi Ge

CONTACT

+861056981098; ge_jingyi2020@163.com

Hongying Jiang, MD

CONTACT

+861056981098; 6jhy@163.com

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: October 16, 2026

Record last verified: 2026-10

Locations

CN (4)