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

9. juni 2026 oppdatert av: Hongying Jiang, MD

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

800

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Hongying Jiang, MD
  • Telefonnummer: +861056981098
  • E-post: 6jhy@163.com

Studiesteder

  • Kina
    • Anhui
      • Huaibei, Anhui, Kina
        • Har ikke rekruttert ennå
        • Anhui Wanbei Rehabilitation Hospital
        • Ta kontakt med:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100043
        • Rekruttering
        • Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
        • Ta kontakt med:
          • Hong ying Jiang
          • Telefonnummer: +8601056981555
          • E-post: 6jhy@163.com
    • Hunan
      • Hunan, Hunan, Kina, 410000
        • Har ikke rekruttert ennå
        • Hunan Rehabilitation Hospital
        • Ta kontakt med:
    • Zhengzhou
      • Henan, Zhengzhou, Kina, 450007
        • Har ikke rekruttert ennå
        • Zhengzhou Central Hospital Affiliated to Zhengzhou University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
post-intensive care syndrome group
PICS patients who come from a general hospital ICU and are transferred to a participating HDU
Annen: 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 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MRC Sum Score for Muscle Strength
Tidsramme: Collect 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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
ICU Mobility Scale Score
Tidsramme: Collect 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.
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
Tidsramme: 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 (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
Tidsramme: Collect 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.)
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
PHQ-9 Score for Depression
Tidsramme: Collect 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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.
GAD-7 Score for Anxiety
Tidsramme: Collect 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.
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
Tidsramme: Collect 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.
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
Tidsramme: Collect 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.
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
Tidsramme: Collect 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.
Collect data within 24 hours after admission to the HDU or within 24 hours before discharge from the ICU.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hongying Jiang, MD

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. mai 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. mai 2027

Datoer for studieregistrering

Først innsendt

1. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026bkky-dzx-PICS

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

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