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Development of an Early Warning Model for Intensive Care Unit-Acquired Weakness in Mechanically Ventilated Children

NCT07150637 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2026-03-19

No results posted yet for this study

Summary

Acquired weakness (AW) is a common complication among patients in the Intensive Care Unit (ICU). It is a systemic muscle weakness and dysfunction associated with critical illness, often related to prolonged bed rest, mechanical ventilation, systemic inflammatory response syndrome (SIRS), and multiple organ dysfunction syndrome (MODS). The primary clinical manifestations include weakness in limb and respiratory muscles, particularly diminished strength in distal muscle groups. As a result, the weaning process from mechanical ventilation becomes more challenging, leading to prolonged ICU stays, increased mortality, and a higher risk of long-term functional disability. The significance of AW lies not only in its substantial impediment to short-term recovery but also in its role as a core component of Post-Intensive Care Syndrome (PICS), profoundly affecting patients' long-term outcomes.

Mechanical ventilation is a vital life-support technology for critically ill children in the Pediatric Intensive Care Unit (PICU). However, complications associated with mechanical ventilation have garnered increasing attention, particularly Acquired Weakness in mechanically ventilated children. With improving survival rates in the PICU, a growing number of pediatric critical illness survivors are at risk of developing AW. Despite rapid advancements in pediatric critical care medicine in China, there is currently a lack of an early warning system for AW in children receiving mechanical ventilation, resulting in significantly delayed clinical interventions. This project aims to identify novel biomarkers for pediatric ICU-AW and develop an early warning model. It holds promise for transitioning from the traditional post-symptomatic diagnostic approach to subclinical prediction of AW in children, which is of great clinical value for reducing disability rates and optimizing critical care rehabilitation strategies.

Conditions

  • ICU Acquired Weakness

Interventions

DIAGNOSTIC_TEST

ICU-AW

The enrolled children receiving mechanical ventilation were grouped based on the occurrence of ICU-acquired weakness (ICU-AW) at the study endpoint.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-12-31
Completion
2028-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150637 on ClinicalTrials.gov